FDA 510(k) Applications Submitted by J B WANG

FDA 510(k) Number Submission Date Device Name Applicant
K010271 01/29/2001 THINKINGNET THINKING SYSTEMS CORP.
K221039 04/07/2022 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 Shenzhen AOJ Medical Technology Co., Ltd.
K221170 04/22/2022 Forehead Thermometer, models AOJ-F101, AOJ-F102, AOJ-F103, AOJ-F104 AOJ-F105, AOJ-F106, AOJ-F107 Shenzhen AOJ Medical Technology Co., Ltd.
K222125 07/18/2022 Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F and AOJ-30G Shenzhen AOJ Medical Technology Co., Ltd.
K222994 09/28/2022 Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B Shenzhen AOJ Medical Technology Co., Ltd.
K062873 09/25/2006 SUNPOLAR HEALTHLINE, MODEL 100; COMPFRESH, MODEL 200; NATUREX , MODEL 300; AND IHEALTH, MODEL 400 STOCKINGS E.C.I. USA CORPORATION
K092683 09/01/2009 DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL LD 1143 SHANGHAI LITTLE DOCTOR CO. LIMITED
K093359 10/28/2009 1103 DIGITAL BLOOD PRESSURE MONITOR, MODEL LD 1103, 1133 DIGITAL BLOOD PRESSURE MONITOR, MODEL LD 1133 SHANGHAI LITTLE DOCTOR CO. LIMITED
K090992 04/07/2009 WELL-PASTE VERICOM CO., LTD.
K010191 01/22/2001 Y2000 POCKET RESCUE CHEEN HOUNG ENT. CO. LTD.
K970688 02/25/1997 POCKET RESCUE CHEEN HOUNG ENT. CO. LTD.
K981415 04/20/1998 0-20 CM H20 PEEP VALVE CHEEN HOUNG ENT. CO. LTD.
K021390 05/02/2002 PMX COMPACT RESUCITATOR CHEEN HOUNG ENT. CO. LTD.
K003927 12/20/2000 Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUGH02 CHEEN HOUNG ENT. CO. LTD.
K120305 02/01/2012 THINKINGNET, THINKINGPACS/RIS - PROPRIETARY NAME FRO THINKINGNET, THINKINGARCHIVE (OR NUPAX) - THE MANAGEMENT AND ARCHIV THINKING SYSTEMS CORP.
K181943 07/20/2018 OSCAR (OSCAR Prime, OSCAR Classic) Genoray Co., Ltd.
K083299 11/10/2008 TAIDOC TD-11 SERIES AND CLEVER TD-1112 EAR/SKIN/ SURFACE IR THERMOMETERS & FORA IR16/17 EAR THERMOMETER TaiDoc Technology Corporation
K983450 09/30/1998 STARRYSHINE GAUZE SPONGE T.C. DENTAL PRODUCTS, INC.
K221744 06/16/2022 STRATAFIXÖ Spiral MONOCRYLÖ Plus Knotless Tissue Control Device Ethicon, Inc.
K190112 01/23/2019 Non-Sterile Zirconia Block Fine Advanced Compound Co., Ltd
K960319 01/23/1996 A & D UB-302 WRIST DIGITAL BLOOD PRESSURE MONITOR A & D ENGINEERING, INC.
K170196 01/23/2017 A&D Medical UB-1100BLE UltraConnect Digital Blood Pressure Monitor A&D Company, Ltd.
K040229 02/02/2004 A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODEL UB-328 A & D ENGINEERING, INC.
K040371 02/17/2004 A & D MEDICAL UA-767BT DIGITAL BLOOD PRESSURE MONITOR A & D ENGINEERING, INC.
K980824 03/04/1998 A&D UB-322 WATCH STYLE WRIST DIGITAL BLOOD PRESSURE MONITOR A & D ENGINEERING, INC.
K010828 03/20/2001 DIGITAL BLOOD PRESSURE MONITORS, MODELS TM-2655, TM-2655P, & TM-2655VP A & D ENGINEERING, INC.
K141160 05/05/2014 A&D MEDICAL UA-651 DIGITAL BLOOD PRESSURE MONITOR A & D CO., LTD.
K141179 05/07/2014 A&D MEDICAL UB-543 DIGITAL BLOOD PRESSURE MONITOR A & D CO., LTD.
K141201 05/09/2014 A&D MEDICAL UA-767F AND UA-767FAC DIGITAL BLOOD PRESSURE MONITOR A & D CO., LTD.
K061456 05/25/2006 A & D MEDICAL UM-101 DIGITAL BLOOD PRESSURE MONITOR A & D ENGINEERING, INC.
K111686 06/16/2011 A & D MEDICAL UA-1000 FAMILY DAGITAL BLOOD PRESSURE MONITORS A&D COMPANY, LTD.
K012013 06/28/2001 LIFESOURCE MODELS UA-787, UA 787PC, UA-787T A & D ENGINEERING, INC.
K002061 07/06/2000 A&D MEDICAL TM-2550/TM-2551/TM-2560 VITAL SENSOR MONITOR A & D ENGINEERING, INC.
K002115 07/13/2000 A&D MEDICAL LIFESOURCE UB-401PC & UB-401 DIGITAL BLOOD PRESSURE MONITORS A & D ENGINEERING, INC.
K151953 07/15/2015 A&D Medical TM-2657 Family of Digital Blood Pressure Monitors A&D COMPANY, LTD
K982481 07/16/1998 A&D MEDICAL UA-767PC DIGITAL BLOOD PRESSURE MONITOR A & D ENGINEERING, INC.
K062027 07/18/2006 A&D MEDICAL UA-789 DIGITAL BLOOD PRESSURE MONITOR A & D ENGINEERING, INC.
K012472 08/02/2001 A & D MEDICAL LIFESOURCE UA-781, UA781PC, & UA-781T DIGITAL BLOOD PRESSURE MONITORS A & D ENGINEERING, INC.
K032499 08/13/2003 A & D MEDICAL LIFESOURCE UA-704 DIGITAL BLOOD PRESSURE MONITORS A & D ENGINEERING, INC.
K992808 08/20/1999 A&D MEDICAL TM-2430 AND TM-2431 AMBULATORY BLOOD PRESSURE A&D MEDICAL DIV.
K082734 09/18/2008 A&D MEDICAL UA-851THW DIGITAL BLOOD PRESSURE MONITOR A & D ENGINEERING, INC.
K993116 09/20/1999 A&D MEDICAL UT-101 LIFESOURCE DIGITAL EAR THEROMETER A & D ENGINEERING, INC.
K173065 09/29/2017 A&D Medical Blood Pressure Monitors A&D Company, Ltd
K173191 10/02/2017 A&D Medical Blood Pressure Monitors A&D Company, Ltd.
K042967 10/28/2004 A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODELS UB-511 & UB-512 A & D ENGINEERING, INC.
K993888 11/16/1999 A & D MEDICALLIFESOURCE US-779PC & UA-779T DIGITAL BLOOD PRESSURE MONITORS A & D ENGINEERING, INC.
K043217 11/22/2004 A&D MEDICAL UA-767PBT DIGITAL BLOOD PRESSURE MONITOR A & D ENGINEERING, INC.
K163683 12/28/2016 A&D Medical UA-1200BLE UltraConnect Digital Blood Pressure Monitor A&D COMPANY, LTD
K210432 02/12/2021 LELTEK Ultrasound Imaging System (Model: LU700 Series) Leltek Inc
K152093 07/28/2015 NobelZygoma 45░ NOBEL BIOCARE AB
K201581 06/11/2020 CPR BAND CREDO
K170047 01/05/2017 All-in-One Health Monitor, PC-303 Shenzhen Creative Industry Co., Ltd.
K150093 01/16/2015 Pulse Oximeter, Models PC-66A; PC-66B; PC-66C;PC-60B1; PC-60B5; PC-60D; PC-60D2; PC-60E; PC-60N; POD-1; POD-2; POD-3; PC-68A; PC-68B; PC-68C; POD- 1W; and POD-60NW-1 SHENZHEN CREATIVE INDUSTRY CO., LTD.
K201468 06/02/2020 Pulse Oximeter Shenzhen Creative Industry Co., Ltd.
K192343 08/28/2019 Patient Monitor Shenzhen Creative Industry Co., Ltd.
K172792 09/15/2017 Handheld Pulse Oximeter, Model SP-20 Shenzhen Creative Industry Co., Ltd.
K212867 09/08/2021 Medical Surgical Mask Nanchang Kanghua Health Materials Co., Ltd
K160341 02/08/2016 Colposcope System XUZHOU KERNEL MEDICAL EQUIPMENT CO., LTD
K200971 04/13/2020 308nm Excimer System Xuzhou Kernel Medical Equipment Co., Ltd.
K181805 07/06/2018 UV Phototherapy Xuzhou Kernel Medical Equipment Co., LTD.
K211583 05/24/2021 Infrared Thermometer, Model: HW-1 Dongguan SIMZO Electronic Technology Co.Ltd.
K221868 06/27/2022 QOCA image Smart CXR Image Processing System Quanta Computer Inc.
K110719 03/15/2011 ORIGIN ZIRCONIA B&D DENTAL TECHNOLOGIES
K042586 09/22/2004 BEST BREAST BRACHYTHERAPY APPLICATOR BEST MEDICAL INTERNATIONAL, INC.
K042786 10/06/2004 BEST MODEL # 81-01 SERIES IR-192 SOURCES BEST MEDICAL INTERNATIONAL, INC.
K043117 11/10/2004 BEST RADIOPAQUE STRAND; BEST RADIOPAQUE MARKER BEST MEDICAL INTERNATIONAL, INC.
K130053 01/15/2013 BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BI BIO-RAD LABORATORIES, INC.
K170413 02/10/2017 BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set Bio-Rad Laboratories
K120439 02/13/2012 BIOPLEX 2200 EBV IGG AND SYPHILIS IGG BIO-RAD LABORATORIES, INC.
K120572 02/27/2012 BIOPLEX 2200 TORC IGG BIO-RAD LABORATORIES, INC.
K130528 03/01/2013 BIOPLEX 2200 APLS IGM Bio-Rad Laboratories
K120959 03/30/2012 BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT Bio-Rad Laboratories
K111072 04/18/2011 BIOPLEX 2200 MMRV IGG IT ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, BIOPLEX 2200 MMRV IGG CALIBRATOR SET, AND BIOPL Bio-Rad Laboratories
K141114 04/30/2014 BIOPLEX(R) 2200 25-OH VITAMIN D KIT, BIOPLEX(R) 2200 25-OH VITAMIN D CALIBRATOR SET, AND BIOPLEX(R) 2200 25-OH VITAMIN D Bio-Rad Laboratories
K112810 09/27/2011 MULTI-ANALYTE DETECTION SYSTEMS Bio-Rad Laboratories
K123021 09/27/2012 BIOPLEX 2200 EBV IGM KIT Bio-Rad Laboratories
K113610 12/06/2011 ANA-SCREEN WITH MDSS Bio-Rad Laboratories
K093954 12/23/2009 BIOPLEX 2200 ANTI-CCP KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM Bio-Rad Laboratories
K103834 12/30/2010 BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS Bio-Rad Laboratories


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