FDA 510(k) Applications for Medical Device Product Code "FLL"
(Thermometer, Electronic, Clinical)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K993116 | A & D ENGINEERING, INC. | A&D MEDICAL UT-101 LIFESOURCE DIGITAL EAR THEROMETER | 04/12/2000 |
| K060173 | ACON LABORATORIES, INC. | ACON 30 SECOND RELIABLE DIGITAL THERMOMETER, ACON DIGITAL THERMOMETER PROBE COVERS | 03/17/2006 |
| K063418 | ACON LABORATORIES, INC. | ACON DIGITAL THERMOMETER PROBE COVERS | 02/02/2007 |
| K083419 | ACTHERM, INC. | ACTHERM DIGITAL CLINICAL THERMOMETER PROBE COVERS, MODEL(S) MEDACCU1010, MEDACCU1010-1, MEDACCU1020 | 07/16/2009 |
| K010238 | ACTHERM, INC. | ACTHERM DIGITAL CLINICAL THERMOMETER, MODELS ACT2000, ACT2010, ACT2000+, ACT2010+, ACT2020+ | 02/06/2001 |
| K093795 | ACTHERM, INC. | ACTHERM INFRARED EAR THERMOMETER ACT 8000R SERIES AND ITS PROBE COVER MED ACCU2010 | 03/12/2010 |
| K090031 | ACTHERM, INC. | ACTHERM INFRARED EAR THERMOMETER, ACT 8000 SERIES; PROBE COVER FOR ACTHERM INFRARED EAR THERMOMETER, MODEL MEDACCU2010 | 04/16/2009 |
| K070028 | ACTHERM, INC. | CLASSIC/HYPOTHERMIA, FLEXIBLE, 10-SECOND, LEFT-RIGHT HANDED, BASAL, LIGHTWEIGHT-PROBE DIGITAL CLINICAL THERMOMETER | 02/08/2007 |
| K021614 | ACTHERM, INC. | DIGITAL CLINICAL THERMOMETER, MODEL ACT 3020 | 05/30/2002 |
| K021612 | ACTHERM, INC. | DIGITAL CLINICAL THERMOMETER, MODELS ACT 2030, 2038 | 05/30/2002 |
| K031905 | ACTHERM, INC. | DIGITAL CLINICAL THERMOMETER, MODELS ACT2130, ACT 2230, ACT 2330, ACT 3136, AND ACT 3030 | 07/07/2003 |
| K023711 | ACUTE IDEAS CO. LTD. | DIGITAL THERMOMETER CLASSIC TYPE AND FLEXIBLE TYPE | 11/21/2002 |
| K172508 | Ageless Health Industrial Co., Ltd | Ageless Health Medical Digital Thermometer | 08/08/2018 |
| K232010 | AION Biosystems Inc. | iTEMPSHIELD | 08/04/2023 |
| K971866 | ALEXANDER MFG. CO. | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS61010 | 07/03/1997 |
| K970271 | ALEXANDER MFG. CO. | ALEXANDER MANUFACTURING COMPANY | 04/02/1997 |
| K180207 | Alicn Medical (Shenzhen), Inc | Non-contact Infrared Thermometer | 11/28/2018 |
| K210564 | Alicn Medical Shenzhen, Inc | Infrared Thermometer | 01/07/2022 |
| K222248 | Alicn Medical Shenzhen, Inc | Infrared Thermometer | 06/07/2023 |
| K212257 | Alicn Medical Shenzhen, Inc. | Electronic Thermometer, Model: AET-E201, AET-E211, AET-E221, AET-E231, AET-E241, AET-E251, AET-E301, AET-E311 | 05/04/2022 |
| K210937 | Alicn Medical Shenzhen, Inc. | Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241 | 05/12/2022 |
| K210565 | Alicn Medical Shenzhen,Inc | Infrared Thermometer, Model: AET-R1B1, AET-R161, AET-R171, AET-R1D1, AET-R1D2, AET-R1F1, AET-R701, AET-R711 | 05/05/2022 |
| K070342 | AMERICAN I.V. PRODUCTS, INC. | CLINICAL ELECTRONIC THERMOMETER, MODELS TP11403 THROUGH TP11413 | 03/19/2007 |
| K112116 | AMPEROR-ELECTRONIC(SZ) CO., LTD | DIGITAL CLINICAL THERMOMETER MODEL V901US | 10/04/2011 |
| K082266 | AMPEROR-ELECTRONIC(SZ) CO., LTD | DIGITAL CLINICAL THERMOMETER MODEL V9XX | 11/07/2008 |
| K042575 | AMPLIFE CORPORATION | AMPLIFE DIGITAL CLINICAL THERMOMETER | 09/30/2004 |
| K042906 | AMPLIFE CORPORATION | AMPLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL E101 | 11/19/2004 |
| K202791 | Andon Health Co., Ltd. | iHealth Clinical Digital Thermometer | 01/05/2021 |
| K212598 | Andon Health Co., Ltd. | iHealth infrared Ear thermometer PT5 | 01/28/2022 |
| K200531 | Andon Health Co., Ltd. | iHealth Infrared No-Touch Forehead Thermometer | 07/15/2020 |
| K202753 | Andon Health Co., Ltd. | iHealth Wireless No-Touch Forehead Thermometer | 03/08/2021 |
| K200710 | Andon Health Co., Ltd. | Infrared PT2L Digital No-Touch Thermometer | 10/01/2020 |
| K152905 | ARC DEVICES LIMITED | ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch Thermometer | 07/20/2016 |
| K120412 | ARIZANT HEALTHCARE INC. | 3M SPOTON TEMPERATURE MONITORING SYSTEM | 05/30/2012 |
| K012136 | AVITA CORPORATION | AVITA AGIL IT 101 INSTANT DIGITAL THERMOMETER | 09/10/2001 |
| K110559 | AVITA CORPORATION | AVITA INFRARED THEROMETER WITH BLUETOOTH | 01/06/2012 |
| K010462 | AVITA CORPORATION | AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES) | 04/11/2001 |
| K092959 | AVITA CORPORATION | AVITA RADAR THERMO IR THERMOMETER, MODEL NT 152 | 11/27/2009 |
| K081160 | AVITA CORPORATION | AVITA RADAR THERMO IR THERMOMETER, NT1 SERIES | 06/24/2008 |
| K172427 | Avita Corporation | AViTA Radar Thermo NT16 Series IR Thermometer | 04/19/2018 |
| K100016 | AVITA CORPORATION | AVITA SCANEO INFRARED EAR THERMOMETER, MODEL TS7 | 03/04/2010 |
| K102554 | AVITA CORPORATION | AVITA SCANEO IR THERMOMETER MODEL TS4X SERIES | 03/03/2011 |
| K092958 | AVITA CORPORATION | AVITA SCANEO IR THERMOMETER, MODELS TS2X & TS3X SERIES | 12/02/2009 |
| K031503 | AVITA CORPORATION | AVITA TS8/TS9 SERIES IR EAR/FOREHEAD THERMOMETER | 10/24/2003 |
| K002182 | AVITA CORPORATION | AVITA TSO/TS1 INFRARED EAR THERMOMETER | 12/29/2000 |
| K983406 | BANTA HEALTHCARE GROUP, LTD. | SANITHERM ORAL DISPOSABLE THERMOMETER SHEATHS FOR MERCURY THERMOMETER, SENITHERM ORAL DISPOSABLE THERMOMETER SHEATHS FOR | 10/19/1998 |
| K983619 | BARCHENS CO. | BARCHENS COMPANY DIGITAL PACIFIER THERMOMETER | 11/02/1998 |
| K971994 | BECTON DICKINSON CONSUMER PRODUCTS | B-D ASSURE EAR THERMOMETER | 05/01/1998 |
| K211752 | Beijing Choice Electronic Technology Co., Ltd. | Infrared Thermometer | 01/21/2022 |
| K161211 | BIOCARE ASIA CORPORATION LTD. | Digital Thermometer | 08/29/2016 |
| K132457 | BIOCARE ASIA CORPORATION LTD. | FORA DIAMOND NEXUS MINI INFRARED FOREHEAD THERMOMETER | 02/21/2014 |
| K213011 | Bioland Technology Ltd | Infrared Thermometer (model: E201) | 04/05/2022 |
| K201879 | Bioland Technology Ltd. | Digital Thermometer Model T103, T104 | 03/31/2021 |
| K201161 | Bioland Technology Ltd. | Infrared Thermometer Model E127 | 10/02/2020 |
| K201977 | Blue Spark Technologies Inc. | TempTraq | 12/03/2020 |
| K143267 | Blue Spark Technologies Inc. | TempTraq TT-100 | 09/02/2015 |
| K210924 | BodyCAP | e-Celsius Medical System | 06/28/2023 |
| K100843 | BRAIN TUNNELGENIX TECHNOLOGIES CORP | ABREU, MODEL 700 | 08/17/2010 |
| K983295 | BRAUN AG | BRAUN THERMOSCAN IRT3020/3500 ONE SECONS EAR THERMOMETER, MODEL IRT3020/3520 | 03/15/1999 |
| K060006 | BRAUN GMBH | BRAUN THERMOSCAN IRT 2000 INFRARED EAR THERMOMETER | 01/31/2006 |
| K031928 | BRAUN GMBH | BRAUN THERMOSCAN PRO 4000 SERIES (PROFESSIONAL USE ENVIRONMENT); BRAUN THERMOSCAN IRT 4000 SERIES (HOME USE ENVIRONMENT) | 10/24/2003 |
| K992468 | BRAUN GMBH | BRAUN THERMOSCAN PRO3000 INFARED THERMOMETER | 10/20/1999 |
| K180355 | BroadMaster Biotech, Corp. | Advocate Non-Contact Infrared Thermometer | 01/10/2019 |
| K191004 | BroadMaster Biotech, Corp. | Advocate Non-Contact Infrared Thermometer | 09/05/2019 |
| K083185 | CADI SCIENTIFIC PTE.LTD | CADI SMARTSENSE VITAL SIGNS AND WIRELESS TEMPERATURE MONITORI NG SYSTEM, MODEL S1 | 03/11/2009 |
| K050230 | CARDINAL HEALTH, ALARIS PRODUCTS | TURBO TEMP TRIO | 02/16/2005 |
| K101043 | CHANGSHAN ESTAR ELECTRONICS CO., LTD. | ECT DIGITAL THERMOMETER | 07/21/2010 |
| K120004 | CHINA SHENYANG MED-LAND IMP/EXP CORP., LTD. | (MULTIPLE) DIGITAL THERMOMETER | 08/23/2012 |
| K063291 | CHOICE SMART HEALTH CARE CO. LTD. | INFRARED EAR THERMOMETER, MODEL IRT-21 AND IRT-22 | 11/21/2006 |
| K062016 | CHOICE SMART HEALTH CARE CO. LTD. | RAPID DIGITAL THERMOMETER, MODEL RDT -18 SERIES | 10/27/2006 |
| K070339 | CINCINNATI SUB-ZERO PRODUCTS, INC | DISPOSABLE TEMPERATURE PROBES/SENSORS AND INSTRUMENT CABLES | 09/26/2007 |
| K222311 | CIRCA Scientific, Inc. | CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System | 05/25/2023 |
| K200943 | CIRCA Scientific, LLC | Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System | 12/17/2021 |
| K112376 | CIRCA SCIENTIFIC, LLC | S-CATH ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM | 08/31/2011 |
| K191668 | Comper Chuangxiang (Beijing) Technology Co., Ltd. | Infrared Forehead Thermometer (Model IR-FT) | 10/18/2019 |
| K202481 | Comper Chuangxiang (Beijing) technology Co., Ltd. | ThermArt (Model IR-EFT) | 09/28/2021 |
| K202420 | Conmo Electronic Company Limited | Infrared Forehead Thermometer | 02/25/2021 |
| K201980 | Contec Medical Systems Co., Ltd. | Infrared Thermometer | 12/18/2020 |
| K032434 | COTRONIC MANUFACTURING | CLINICAL ELECTRONIC THERMOMETER | 12/27/2004 |
| K103407 | COTRONIC MANUFACTURING | COTRONIC DIGITAL THERMOMETER | 05/13/2011 |
| K120671 | COTRONIC TECHNOLOGY LIMITED | DIGITAL PACIFIER THERMOMETER (MODEL NO.: TM-03) | 05/17/2013 |
| K200631 | DeRoyal Industries, Inc. | DeRoyal Temperature Monitoring Probe | 12/23/2020 |
| K081162 | DIABETICA SOLUTIONS, INC. | TEMPTOUCH DERMAL THERMOMETER | 05/08/2008 |
| K964643 | DIATEK INSTRUMENTS, INC. | SURETEMP | 01/09/1997 |
| K112189 | DIGIO2 INTERNATIONAL CO., LTD. | THERMO PAL INFRARED EAR THERMOMETER | 01/13/2012 |
| K152508 | DONGGUAN AGELESS HEALTH INDUSTRIAL CO., LTD | Ageless Health Medical Digital Thermometer | 12/31/2015 |
| K193621 | Dongguan E-Test Technology Co., Ltd | Digital Thermometer-(Model BT-301, BT-302, BT-303, BT-305, BT-306, BT-308, BT-311, BT-318) | 11/23/2020 |
| K201508 | Dongguan Prestige Sporting Goods Co., Ltd | Infrared Thermometer | 03/09/2021 |
| K211583 | Dongguan SIMZO Electronic Technology Co.Ltd. | Infrared Thermometer, Model: HW-1 | 09/03/2021 |
| K173048 | Dongguan SIMZO Electronic Technology Co.Ltd. | No-contact Forehead Thermometer | 12/06/2018 |
| K202591 | Dongguan Xintai Instrument Co., Ltd. | Body Infrared Thermometer HT-820D | 03/09/2021 |
| K121999 | DRAEGER MEDICAL GMBH | GENERAL PURPOSE TEMPERATURE PROBE, SKIN TEMPERATURE PROBE | 02/28/2013 |
| K992327 | DUTECK INDUSTRIAL CO., LTD. | DUTECK DIGITAL CLINICAL THERMOMETER | 08/18/1999 |
| K132140 | DUTECK INDUSTRIAL CO., LTD. | DUTECK(MICHEALTH)DIGITAL CLINICAL THERMOMETER | 02/04/2014 |
| K021601 | DUTECK INDUSTRIAL CO., LTD. | MICHEALTH ET 1100/ET 1200 INFARED EAR THERMOMETER | 07/10/2002 |
| K170723 | E-Care Technology Co., Ltd. | Swaive Thermometer SWT1A | 10/25/2018 |
| K021753 | E-CARE TECHNOLOGY CORPORATION | E-CARE INFARED EAR THERMOMETER, MODEL LCT-200 | 08/06/2002 |
| K113095 | E-CARE TECHNOLOGY CORPORATION | E-CARE INFRARED EAR THERMOMETER | 03/02/2012 |
| K162509 | EASYWELL BIOMEDICALS, INC. | Infrared Non-contact Thermometer, Model ACT8100 | 03/10/2017 |
| K170769 | ECH (Changzhou) Medical Instrument Co., Ltd. | wireless thermometer | 07/26/2017 |
| K971831 | EJB MEDICAL, INC. | QUICK CHECK INSTANT THERMOMETER | 05/07/1998 |
| K961365 | ENDOCARE, INC. | ENDOCARE ELECTORNIC THERMOMETER SYSTEM | 08/15/1996 |
| K964851 | ENTRACARE CORP. | ENTRACARE THERMOMTER MODEL 1000 | 02/03/1997 |
| K981708 | EXCEL PORCELAIN PRODUCTS | DENTAL PORCELAIN-VARIOUS | 07/23/1998 |
| K011291 | EXERGEN CORP. | TEMPORALSCANNER THERMOMETER, SENSORTOUCH | 07/12/2001 |
| K962497 | FAICHNEY MEDICAL CO. | Q-TIPS, FAICHNEY, PRIVATE LABEL | 10/08/1996 |
| K072641 | FAMIDOC TECHNOLOGY CO., LTD | DIGITAL ELECTRONIC THERMOMETER, MODEL: FDTH-V0-1 THRU 4. | 11/01/2007 |
| K113761 | FAMIDOC TECHNOLOGY CO., LTD | INFRARED THERMOMETER | 09/07/2012 |
| K052849 | FAMIDOC TECHNOLOGY CO., LTD | INFRARED THERMOMETER, FDIR-V1 | 10/26/2005 |
| K123361 | FIAB SPA | ESOTEST ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM | 02/27/2013 |
| K180047 | Fiab SpA | ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System | 11/08/2018 |
| K192210 | Fiab SpA | ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System | 10/10/2019 |
| K121118 | FORA CARE INC. | FORA COMFORTSCAN EAR THERMOMETER | 06/15/2012 |
| K111703 | FUDAKANG INDUSTRIAL CO LTD | INFRARED EAR THEROMETER | 03/29/2012 |
| K172121 | Fudakang Industrial Co., Ltd | Digital Thermometer | 06/07/2018 |
| K160308 | Fudakang Industrial Co., Ltd | Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT) | 07/15/2016 |
| K101387 | FUDAKANG INDUSTRIES CO., LTD | DIGITAL THERMOMETER, MODELS BT-A11CN, BT-A21CN, BT-A41CN | 08/03/2010 |
| K152640 | FUDAKANG INDUSTRIES CO., LTD | Infrared Thermometer (FT-F11-BT, FT-F21-BT, FT-31-BT, FT-F41-BT) | 03/28/2016 |
| K003326 | FUNAI RADIO & COMMUNICATIONS CORP. | FUNET AMY MAMA BODY THERMOMETER | 04/11/2001 |
| K051873 | GE HEALTHCARE | DISPOSABLE TEMPERATURE, SKIN AND ESOPHAGEAL PROBES | 09/20/2005 |
| K050837 | GE HEALTHCARE | REUSABLE TEMPERATURE PROBES (M1024254 SKIN TEMPERATURE PROBE, REUSABLE; M1024247, GP TEMPERATURE PROBE, ADULT, RESUABLE | 04/27/2005 |
| K061942 | GE HEALTHCARE | TYMPANIC TEMPERATURE PROBE WITH FOAM, MODEL M1024233; WITHOUT FOAM MODEL M1024237 | 09/29/2006 |
| K003223 | GEON CORP. | GEON DIGITAL CLINICAL THERMOMETER | 01/12/2001 |
| K952001 | GEON CORP. | GEON ELECTRONIC THERMOMETER | 10/18/1996 |
| K100563 | GEON CORPORATION | GEON RAPID DIGITAL THERMOMETER MODEL: MT-B117, MT-B127, MT-B130, MT-B132FA | 06/02/2010 |
| K001281 | GERATHERM AG | GERATHERM BABYWATCH TEMPERATURE MONITOR | 06/12/2001 |
| K030673 | GLOBAL TREASURE INDUSTRIES LTD. | FLEXIBLE TIP THERMOMETER, MODEL 011206 | 04/04/2003 |
| K021052 | GLOBAL TREASURE INDUSTRIES LTD. | MODEL GT010706 ELECTRONIC THERMOMETER | 04/09/2002 |
| K062010 | GLOBAL TREASURE INDUSTRIES LTD. | RAPID DIGITAL THERMOMETER, MODEL RDT -18 SERIES | 10/27/2006 |
| K030658 | GLOBAL TREASURE INDUSTRIES LTD. | STANDARD THERMOMETER | 03/25/2003 |
| K001279 | GLOBAL TREASURE LTD. | GT990402 DIGITAL THERMOMETER | 04/28/2000 |
| K021028 | GLOBAL TREASURE LTD. | MODEL GT980201 ELECTRONIC THERMOMETER | 04/08/2002 |
| K061007 | GOOD MEDY ENTERPRISE LTD. | GOOD MEDY, DISPOSABLE THERMOMETER SHEATHS | 06/14/2006 |
| K210014 | Guandong Genial Technology CO., LIMITED | Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85) | 06/04/2021 |
| K152739 | GUANGDONG BIOLIGHT MEDITECH CO., LTD | Electronic Thermometer | 02/09/2016 |
| K213746 | Guangzhou Berrcom Medical Device Co., Ltd. | Digital thermometer, Model DT101, DT102 | 04/05/2022 |
| K214077 | Guangzhou Berrcom Medical Device Co., Ltd. | Digital Thermometer, Model: DT007, DT008 | 01/20/2023 |
| K213079 | Guangzhou Berrcom Medical Device Co., Ltd. | Ear Thermometer, Model ET001 | 02/18/2022 |
| K213084 | Guangzhou Berrcom Medical Device Co., Ltd. | Ear Thermometer, Model ET005, ET008, ET009 | 02/25/2022 |
| K191570 | Guangzhou Berrcom Medical Device Co., Ltd. | Infrared Thermometer Model MD-H30 | 11/13/2019 |
| K213082 | Guangzhou Berrcom Medical Device Co., Ltd. | Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311 | 01/28/2022 |
| K160306 | GUANGZHOU BOSMA TECHNOLOGY CO LTD | Cloud Smart Thermometer | 12/13/2016 |
| K163603 | Guangzhou Jinxinbao Electronic Co., Ltd | Digital Thermometer | 06/06/2017 |
| K230298 | Hadleigh Health Technologies | Celsi Monitor | 08/16/2023 |
| K041694 | HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO., | DIGITAL FLEXIBLE THERMOMETER, BASIC DIGITAL THERMOMETER, DITITAL PACIFIER THERMOMETER | 09/13/2004 |
| K122912 | HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO., | DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER) | 11/07/2012 |
| K092447 | HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO., | DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER), DT SERIES | 01/07/2010 |
| K041692 | HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO., | INFRARED EAR THERMOMETER, ET-100 SERIES | 09/13/2004 |
| K030361 | HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO., | JASUN, MODELS DT-01F AND DT-11F | 02/21/2003 |
| K160999 | HANGZHOU HUA'AN MEDICAL&HEALTH INSTRUMENTS CO., LTD | Infra-red forehead thermometer | 08/01/2016 |
| K172861 | Hangzhou Hua'an medical&health instruments Co.,Ltd | Digital thermometer(with disposable thermometer cover) | 12/19/2017 |
| K172870 | Hangzhou Hua'an medical&health instruments Co.,Ltd | Infra-red ear thermometer model: ET-100A, ET-100B, ET-100D, ET-100E, ET-100G, ET-100I, ET-100J | 02/13/2018 |
| K201536 | Hangzhou Qingyuan Medical Equipment Technology Co., Ltd. | Infrared Forehead Thermometer | 02/10/2021 |
| K160802 | HANGZHOU UNIVERSAL ELECTRONIC CO., LTD. | Infrared Forehead Thermometer, FT-100A | 08/24/2016 |
| K092557 | HARVARD MEDICAL DEVICES LTD. | DIGITAL THERMOMETER,HMCDT-002/KINETIK BRANDED DT1 SERIES | 12/17/2009 |
| K081061 | HARVARD MEDICAL DEVICES LTD. | HARVARD MEDICAL DEVICES IR EAR THERMOMETER, MODELS HMIRET-002 AND KINETIK BRANDED IET1 SERIES | 07/18/2008 |
| K211744 | Health & Life Co., Ltd | Non-Contact Infrared Thermometer, model HL710H | 11/24/2021 |
| K200781 | HeiTaiDa Technology Co., Ltd. | Infrared Body Thermometer | 12/09/2020 |
| K171888 | Hetaida Technology Co., Ltd | Non-contact infrared body thermometer | 07/23/2018 |
| K180385 | HeTaiDa Technology Co., Ltd. | Infrared Body Thermometer | 05/11/2018 |
| K180387 | HeTaiDa Technology Co., Ltd. | Infrared Ear Thermometer | 01/10/2019 |
| K203332 | HeTaiDa Technology Co., Ltd. | Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C | 02/25/2021 |
| K200159 | HeTaiDa Technology Co., Ltd. | Non-contact Infrared Body Thermometer, model:HTD8823US | 01/05/2021 |
| K020471 | HIVOX BIOTEK, INC. | HIVOX EAR THERMOMETER, TS SERIES | 05/02/2002 |
| K010866 | HOMECARE TECHNOLOGIES LTD. | TEMP-A-SURE | 06/06/2001 |
| K211629 | Honsun (Nantong) Co., Ltd | Infrared forehead thermometer LD-FT-100B | 12/08/2021 |
| K203431 | Huaian Zhongxin Packing Material Co., Ltd. | Disposable Ear Thermometer Probe Cover | 07/28/2021 |
| K043331 | HUBDIC CO., LTD | DIGITAL FOREHEAD THERMOMETER, MODEL FS-100 | 03/04/2005 |
| K101912 | HUBDIC CO., LTD | THE INFRARED FOREHEAD THERMOMETER, MODEL FS-300&301 | 11/10/2010 |
| K023412 | HUBDIC CO., LTD | THERMO BUDDY, MODELS TB-100, TB-110, TB-120 | 04/09/2003 |
| K130361 | HUBDIC CO., LTD | THERMOFINDER; THERMOCARE | 04/02/2013 |
| K191978 | HuBDIC Co., Ltd. | Fever Garde | 12/18/2020 |
| K202111 | Hunan Honggao Electronic Technolofy Co., Ltd. | Medical infrared forehead thermometer | 02/26/2021 |
| K020433 | IDT TECHNOLOGY LIMITED | FT101 FOREHEAD THERMOMETER; FT101 INFRARED DIGITAL THERMOMETER | 07/11/2002 |
| K100660 | INNOCHIPS TECHNOLOGY CO., LTD. | INFRARED EAR THERMOMETER MODEL DR. SCHVEN ICT-1000 | 10/22/2010 |
| K081788 | INNOCHIPS TECHNOLOGY CO., LTD. | INFRARED EAR THERMOMETER, MODELS INNOTHERM ICT-100 AND ICT-200 | 12/17/2008 |
| K023500 | INNOVATECH, INC | DIGITAL CLINICAL THERMOMETER, MODEL BABY TEMP/WL-3305 AND BABY TEMP (+) /WL-3306 | 12/13/2002 |
| K042631 | INNOVATECH, INC | EAR THERMOMETER, MODEL WL-320X | 12/22/2004 |
| K961357 | INTELLIGENT PRODUCT LIMITED CO. | PRO-FLEX, DIGITAL THERMOMETER WITH FLEXIBLE PROBE | 08/16/1996 |
| K163256 | Intelliworks LLC | Dual Mode Infrared Thermometer | 04/06/2017 |
| K102718 | INTERNATIONAL REGULATORY CONSULTANTS, LLC (IRC) | DIGITAL THERMOMETER; DIGITAL THERMOMETER | 12/13/2010 |
| K170662 | Intrinity Global Limited | Non Contact Infrared Forehead Thermometer | 11/22/2017 |
| K202603 | iWEECARE Co., Ltd. | Temp Pal | 07/22/2021 |
| K222588 | iWEECARE Co., Ltd. | Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1 | 02/17/2023 |
| K013876 | JAWON MEDICAL CO., LTD. | INFRARED EAR THERMOMETER, MODEL DX-707 | 03/04/2002 |
| K203583 | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd | YUWELL infrared ear thermometer: YHT101, YHT200 | 05/20/2021 |
| K201864 | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | YUWELL Infrared Thermometer | 12/07/2020 |
| K213038 | Jiaxing Shangjia Intelligence Technology Co., Ltd. | Infrared Forehead Thermometer, model: HS-9802D | 03/10/2022 |
| K130231 | JINXINBAO ELECTRONIC CO.,LTD | NON-CONTACT INFRARED THERMOMETER | 10/15/2013 |
| K211050 | JKH HEALTH CO., LTD. | Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304 | 11/28/2022 |
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| K152402 | SECURUS,INC | IRTS Thermal Imaging Probe (TIP);IRTS Patient Monitoring Unit (PMU);IRTS Patient Interface Unit (PIU) | 03/04/2016 |
| K110776 | SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. | DIGITAL THERMOMETER MT SERIES | 08/24/2011 |
| K153149 | SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. | Digital Thermometer, Models MT-1027, MT-4127, MT-1032, MT-4132, MT-4333, MT-4326, MT-4726, MT-4335, MT-4735, MT-09, MT-30, MT-31, MT-36 | 05/27/2016 |
| K153146 | SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. | Infrared Ear Thermometer | 03/31/2016 |
| K082192 | SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. | INFRARED EAR THERMOMETER, MODEL ET-101A | 09/17/2008 |
| K062784 | SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. | SEJOY DIGITAL THERMOMETER, MT SERIES (MT-201, MT-301, MT-402, MT-403 AND MT-405) | 05/04/2007 |
| K051699 | SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. | SEJOY, MODEL MT-403 | 02/06/2006 |
| K203643 | Sensatronic GmbH | Sensatronic Reusable Temperature Probes | 08/11/2021 |
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| K171578 | Shenzhen Aeon Technology Co.,Ltd. | Infrared thermometer | 11/30/2017 |
| K213485 | Shenzhen AOJ Medical Technology Co., Ltd. | Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25E | 05/25/2022 |
| K221170 | Shenzhen AOJ Medical Technology Co., Ltd. | Forehead Thermometer, models AOJ-F101, AOJ-F102, AOJ-F103, AOJ-F104 AOJ-F105, AOJ-F106, AOJ-F107 | 10/07/2022 |
| K182133 | Shenzhen AOJ Medical Technology Co., Ltd. | Infrared Thermometer | 11/20/2018 |
| K221039 | Shenzhen AOJ Medical Technology Co., Ltd. | Infrared Thermometer, models AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F, AOJ-20H, AOJ-20M, AOJ-20T, AOJ-20R and AOJ-20Y | 12/20/2022 |
| K140681 | SHENZHEN BELTER HEALTH MEASUREMENT AND ANALYSIS TE | BELTER INFRA-RED EAR THERMOMETER | 08/21/2014 |
| K171214 | Shenzhen Brav Electronic Technologies Co., Ltd. | Infrared Thermometer | 03/02/2018 |
| K202296 | Shenzhen BSX Technology Electronics Co., Ltd. | Infrared Forehead Thermometer, Model BSX976 | 07/23/2021 |
| K191251 | Shenzhen Calibeur Industries Co., Ltd. | Infared Thermometer | 10/15/2019 |
| K182755 | Shenzhen Caremed Medical Technology Co., Ltd. | Disposable Temperature Probe | 12/21/2018 |
| K182751 | Shenzhen Caremed Medical Technology Co., Ltd. | Reusable Temperature Probe | 09/06/2019 |
| K193625 | Shenzhen Changke Connect Electronics Co., Ltd. | Disposable Temperature Probe | 07/24/2020 |
| K193253 | Shenzhen Changkun Technology Co., Ltd. | Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503 | 06/17/2020 |
| K202741 | Shenzhen Combei Technology Co., Ltd. | Infrared Forehead Thermometer | 07/07/2021 |
| K100488 | SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. | IR EAR/FOREHEAD THERMOMETER MODE DX6635, DX6637, DTH1081 | 07/22/2010 |
| K073366 | SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. | TALKING CLINICAL ELECTRONIC THERMOMETER, MODELS DX6623B, DT1031 AND DT1041 | 02/08/2008 |
| K051251 | SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD. | INFRARED EAR THEMOMETER, MODELS DX6603, DX66390 | 09/07/2005 |
| K161735 | Shenzhen Dongdixin Technology Co., Ltd. | Non-contact Forehead Thermometer | 11/17/2016 |
| K212945 | Shenzhen Envisen Industry Co., Ltd | Sterile Disposable Temperature Probe | 03/01/2022 |
| K203170 | Shenzhen Everbest Machinery Industry Co., LTD | Infrared Thermometer Models: DT-8806S, DT-8807S | 04/16/2021 |
| K101736 | SHENZHEN EVERBEST MACHINERY INDUSTRY CO., LTD. | NON-CONTACT FOREHEAD INFRARED THERMOMETER, MODEL DT-8806H, BODY INFRARED THERMOMETER, MODEL DT-8806 AND DIGITAL INFRARED | 07/06/2010 |
| K181215 | Shenzhen Finicare Co., Ltd. | Infrared Thermometer | 01/02/2019 |
| K172894 | Shenzhen Jiacom Technology Co ., Ltd | Infrared Thermometer | 05/17/2018 |
| K172874 | Shenzhen Jiacom Technology Co., Ltd | Infrared Thermometer | 07/12/2018 |
| K131243 | SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD | NON-CONTACT INFRARED THERMOMETER | 11/12/2013 |
| K172795 | Shenzhen Jumper Medical Equipment Co., Ltd. | Infrared Thermometer | 03/14/2018 |
| K182437 | Shenzhen Jumper Medical Equipment Co.,Ltd. | Wireless Intelligent Thermometer | 05/05/2019 |
| K202009 | Shenzhen Juzhong Technology Co., Ltd | Probe Cover: JZ-KBT-001, JZ-KBT-002, JZ-KBT-005, JZ-KBT-007, JZ-KBT-008, JZ-KBT-009, JZ-KBT-010, JZ-KBT-015, JZ-KBT-025, JZ-KBT-026 | 03/22/2021 |
| K181967 | Shenzhen Launch Electrical Co., LTD | Disposable Temperature Probe | 12/10/2018 |
| K202687 | Shenzhen LEPU Intelligent Medical Equipment Co., Ltd. | Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60 | 02/18/2021 |
| K193338 | Shenzhen Med-link Electronics Tech Co., Ltd. | Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes | 08/25/2020 |
| K182667 | Shenzhen Med-link Electronics Tech Co., Ltd. | Med-link Temperature Probes | 06/18/2019 |
| K172889 | Shenzhen Pacom Medical Instruments Co., Ltd. | Infrared Thermometer | 05/25/2018 |
| K190717 | Shenzhen Pacom Medical Instruments Co., Ltd. | Infrared Thermometer, model: PC808 | 12/13/2019 |
| K182597 | Shenzhen Pango Electronic Co., Ltd | Infrared thermometer | 04/03/2019 |
| K212346 | Shenzhen Pango Medical Electronics Co., Ltd. | Infrared Thermometer, Model: PG-IRT1612, PG-IRT1613, PG-IRT1615, PG-IRT1618 | 05/05/2022 |
| K131210 | SHENZHEN PUMP MEDICAL SYSTEM CO., LTD. | ELECTRONIC THERMOMETER | 03/18/2014 |
| K223807 | Shenzhen SINO-K Medical Technology Co.,Ltd | Reusable Temperature Probe, Disposable Temperature Probe | 08/25/2023 |
| K202440 | Shenzhen Sonida Digital Technology Co., Ltd | Infrared Thermometer | 06/17/2021 |
| K200802 | Shenzhen Urion Technology Co., Ltd | Infrared Thermometer | 10/07/2020 |
| K201579 | Shenzhen Xunwei Industrial Co., Ltd. | Infrared Thermometer | 01/15/2021 |
| K221211 | Shenzhen Yolanda Technology Co., Ltd | Infrared thermometer | 09/27/2022 |
| K203707 | ShenZhen ZhengKang Technology Co., Ltd. | Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603 | 03/12/2021 |
| K210171 | Sichuan YOUKEDE Medical Equipment Co.,Ltd | Non-contact Infrared Thermometer (Models WL-301, WL-501, WL-601, WL-701) | 03/18/2022 |
| K984506 | SKYLARK DEVICE CO., LTD. | SD-100 SKYEAR THERMOMETER | 07/29/1999 |
| K203731 | Smart Technology Co., Ltd. | DT100 Digital Thermometer | 09/26/2021 |
| K111282 | STARBOARD MEDICAL, LLC | DISPOSABLE TEMPERATURE PROBES / SENSORS AND INTERCONNECT INSTRUMENT CABLES | 08/11/2011 |
| K161325 | STETHOCLOUD PTY. LTD (CLINICLOUD) | CliniCloud Non-contact Thermometer, Model SPL1024 | 06/22/2016 |
| K191283 | Suzhou Melodicare Medical Technology Co.,Ltd. | Infrared Thermometer, Breeze model | 10/18/2019 |
| K200946 | TaiDoc Technology Corporation | Clever Forehead Thermometer / Clever Medical Forehead Thermometer (Model TD-1241) | 04/05/2022 |
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| K061800 | TaiDoc Technology Corporation | CLEVER TD-1112 EAR/SKIN/SURFACE IR THERMOMETER | 07/07/2006 |
| K122520 | TaiDoc Technology Corporation | DIGITAL THERMOMTER | 02/05/2013 |
| K080593 | TaiDoc Technology Corporation | FORA COMFORT 4 IN 1 EAR THERMOMETER, MODEL TD-1116 | 04/02/2008 |
| K120712 | TaiDoc Technology Corporation | FORA COMFORTSCAN EAR THERMOMETER | 06/06/2012 |
| K081445 | TaiDoc Technology Corporation | FORA COMFORTSCAN EAR THERMOMETER, MODELS TD-1261A; TD-1261B | 08/11/2008 |
| K090395 | TaiDoc Technology Corporation | FORA IR20B EAR THERMOMETER, MODEL TD-1261F, FORA IR21B EAR THERMOMETER, MODEL TD-1261E | 03/10/2009 |
| K090294 | TaiDoc Technology Corporation | FORA IR22 EAR THERMOMETER, MODEL TD-1262 | 02/26/2009 |
| K111974 | TaiDoc Technology Corporation | ION HEALTH USB INSTA-SCAN THERMOMETER | 08/15/2011 |
| K122221 | TaiDoc Technology Corporation | NEXUS IR30 NON-CONTACT INFRARED FOREHEAD THERMOMETER | 03/29/2013 |
| K083299 | TaiDoc Technology Corporation | TAIDOC TD-11 SERIES AND CLEVER TD-1112 EAR/SKIN/ SURFACE IR THERMOMETERS & FORA IR16/17 EAR THERMOMETER | 12/10/2008 |
| K152680 | TAIDOC TECHNOLOGY CORPORATION | TD-1035 Thermometer | 05/06/2016 |
| K172733 | TaiDoc Technology Corporation | TD-1035 Thermometer | 10/22/2018 |
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| K010383 | TENGHI CO. LTD | TEMP SCAN | 04/18/2001 |
| K003313 | THE KENDALL COMPANY | FILAC FAS TEMP ELECTRONIC THERMOMETER | 01/11/2001 |
| K131771 | THERMOMEDICS INC. | CAREGIVER PROFESSIONAL CLINICAL THERMOMETER, PRO-TF SERIES | 10/07/2013 |
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| K121427 | UNIMED MEDICAL SUPPLIES INC. | UNIMED TEMPERATURE PROBE | 05/29/2012 |
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| K181013 | VivaLnk Inc. | Fever Scout | 08/21/2018 |
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| K180314 | Xuzhou Yongkang Electronic Science Technology Co., Ltd | Infrared Thermometer | 07/11/2018 |
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| K203662 | Yibin Junxin Electronics Technology Co., Ltd. | Infrared thermometer, Models: YRK-002A, T8, T9, T10, T11 | 09/23/2021 |
| K002727 | YOUNG HEALTH IND. CO., LTD. | YOUNG-HEALTH SUPER EAR THERMOMETER | 06/13/2001 |
| K102508 | YU LONG SHENG TECHNOLOGY CO., LTD | YU LONG SHENG DISPOSABLE THERMOMETER SHEATHS, MODELS YLS-01 AND YLS-02 | 01/10/2011 |
| K021048 | Z7 INTERNATIONAL | THERMOMETER MODELS ST8631 | 04/22/2002 |
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| K221800 | Zhangzhou Easepal Medical Science And Technology Co.,Ltd. | Infrared Thermometer (Model: Y20001, Y20002) | 12/14/2022 |
| K220657 | Zhejiang Rongsheng Industrial Co., Ltd. | Medical Infrared Thermometer (Model: RST-TC59-1001, RST-TC60-1001) | 02/10/2023 |
| K201582 | Zhongshan Jinli Electronic Weighingá Equipment Co., Ltd. | Non-contact Electronic Forehead Infrared Thermometer | 01/15/2021 |
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