FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K961972 |
AEQUITRON MEDICAL, INC. |
MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITOR |
04/18/1997 |
K981728 |
ALEXANDER MFG. CO. |
ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER H134 |
06/26/1998 |
K051779 |
ANDROMED, INC. |
ANDROFLOW - RESPIRATORY RATE MONITOR |
09/30/2005 |
K223246 |
Baxter Healthcare Corproration |
Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense |
11/18/2022 |
K103631 |
BIANCAMED LIMITED |
SLEEPMINDER BREATHING FREQUENCY INDICATOR |
07/21/2011 |
K984431 |
BRAEBON MEDICAL CORP. |
ULTIMA AIRFLOW PRESSURE SENSOR |
12/30/1998 |
K981445 |
BRAEBON MEDICAL CORP. |
ULTIMA AIRFLOW SENSOR, 0510 |
10/05/1998 |
K982216 |
BRAEBON MEDICAL CORP. |
ULTIMA RESPIRATORY EFFORT SENSOR MODELS 0520 AND 0522 |
09/11/1998 |
K001743 |
BRAEBON MEDICAL CORP. |
ULTIMA SMARTBELT, MODEL 0560 |
08/25/2000 |
K200445 |
Circadia Technologies Ltd. |
The C100 Contactless Breathing Monitor |
06/24/2020 |
K111933 |
COVIDIEN |
COVIDIEN NELLCOR RESPIRATION RATE SOFTWARE APPLICATION, VERSION 1.0 |
03/15/2012 |
K040605 |
DYMEDIX, INC. |
DYMEDIX REUSABLE RESPIRATORY EFFORT BELT SENSOR, MODEL 6015 AND DYMEDIX REUSABLE LIMB MOVEMENT SENSOR, MODEL 3100 |
04/26/2004 |
K001030 |
DYMEDIX, INC. |
RESPIRATORY BELT SENSOR, MODEL 6000S; LIMB MOVEMENT SENSOR, MODEL 3000S |
05/11/2000 |
K133661 |
EARLYSENSE LTD. |
CHAIR SENSING UNIT FOR EARLYSENSE SYSTEM |
06/13/2014 |
K131379 |
EARLYSENSE LTD. |
EARLYSENSE |
12/18/2013 |
K120465 |
EARLYSENSE LTD. |
EARLYSENSE (EVERON) SYSTEM |
06/08/2012 |
K171836 |
EarlySense Ltd. |
EarlySense Bed Sensing Unit |
01/04/2018 |
K070375 |
EARLYSENSE LTD. |
EARLYSENSE ES-16 SYSTEM |
11/15/2007 |
K152911 |
EarlySense Ltd. |
EarlySense Insight Sytem |
05/06/2016 |
K082465 |
EARLYSENSE LTD. |
EVERON |
03/25/2009 |
K092062 |
EARLYSENSE LTD. |
EVERON 1.0 |
05/24/2010 |
K953363 |
EDENTEC CORP. |
OXIFLOW DIGITAL RECORDER |
02/06/1996 |
K962781 |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
COROMETRICS MODEL 510 AND 511 MONITOR |
03/06/1997 |
K983449 |
GEREONICS, INC. |
GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR |
02/08/1999 |
K062883 |
GEREONICS, INC. |
GEREONICS ULTRA-PIEZO LIMB MOVEMENT SENSOR |
06/13/2007 |
K991411 |
GEREONICS, INC. |
GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR |
04/28/1999 |
K180079 |
Hill-Rom Inc. |
Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Activation |
05/07/2018 |
K202018 |
Hill-Rom, Inc. |
Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Packs, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Activation |
03/04/2021 |
K100773 |
KAI MEDICAL, INC. |
KAI SPOT MODEL KMS 200 |
06/23/2010 |
K090273 |
KAI SENSORS, INC |
KAI SENSORS NON-CONTACT RESPIRATORY RATE SPOT CHECK, MODEL 100, KAI RSPOT, MODEL 100 |
06/05/2009 |
K190734 |
Linshom Management LLC |
Linshom Respiratory Monitoring Device (LRMD) |
01/30/2020 |
K173976 |
Masimo Corporation |
Masimo Acoustic Respiration Sensors, infant and neonate |
09/05/2018 |
K130570 |
NEUROVISION MEDICAL PRODUCTS, INC. |
NEUROVISION MEDICAL MOTION SENSOR |
12/26/2013 |
K003704 |
OPTOVENT AB |
OPTOVENT RESPONS, OPTOVENT RENEE (OPTOVENT RESPONS WITHOUT PULSE OXIMETRY MODULE) |
02/05/2001 |
K981725 |
OPTOVENT, INC. |
OPTOVENT RESPIRATORY MONITOR MODEL NUMBER RR 9700 |
02/02/1999 |
K122223 |
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH |
NEW: INTELLIVUE CL RESPIRATION POD NEW: SPECIALIZED ASSESSORY: MOBILE CL RESP ATTACHMENT MODIFIED: INTELLIVUE PATIENT MO |
04/12/2013 |
K132320 |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN |
INTELLIVUE CL RESPIRATION POD |
03/26/2014 |
K220111 |
PMD Solutions |
RespiraSense |
10/07/2022 |
K151940 |
PneumaCare LIMITED |
Thora-3Di, Model T-01 |
03/10/2016 |
K960851 |
PRO-TECH SERVICES, INC. |
THERMISTOR CANNULA STYLE,SINGLE ELEMENT,ADAM SHELL THERMISTOR AIRFLOW SENSOR |
09/17/1996 |
K223681 |
Respiree PTE Ltd. |
Respiree Cardio-Respiratory Monitor |
03/08/2023 |
K982550 |
RESPIRONICS, INC. |
BROWSER (EVENT SOFTWARE) MODEL # 4500E |
10/05/1998 |
K092685 |
SALTER LABS |
PNEUMOTHERML, MODEL: 5800 |
11/24/2009 |
K080922 |
SALTER LABS, DIVISION OF REGULATORY AFFAIRS |
SALTER LABS ORAL/NASAL THERMAL AIRFLOW SENSOR |
07/25/2008 |
K190775 |
Shenzhen Fiber Medical Technology Co. Ltd. |
The RHEA Vital Sign Vigilance System |
12/19/2019 |
K211387 |
Sound Life Sciences, Inc. |
Breathe Easy Mobile Respiratory Monitor (MRM) |
11/23/2021 |
K221555 |
Turtle Shell Technologies Private Limited |
Dozee VS |
12/15/2022 |