FDA 510(k) Applications for Medical Device Product Code "BZQ"
(Monitor, Breathing Frequency)

FDA 510(k) Number Applicant Device Name Decision Date
K790304 ABBOTT MEDICAL ELECTRONICS CO. PREAMPLIFIER MODULE, EKG RESPIRATION 02/27/1979
K853084 AEQUITRON MEDICAL, INC. MEDICON MODEL 8200 AMS(APNEA MONITOR SYSTEM) 08/02/1985
K901656 AEQUITRON MEDICAL, INC. MODEL 9200 RESPIRATION/HEART RATE MONITOR 07/13/1990
K881266 AEQUITRON MEDICAL, INC. MODEL 9216 RESPIRATION/HEART RATE MONITOR 06/10/1988
K884637 AEQUITRON MEDICAL, INC. MODEL 9550/9500 RESPIRATION/HEART RATE MONITOR 01/30/1989
K961972 AEQUITRON MEDICAL, INC. MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITOR 04/18/1997
K871551 AEQUITRON MEDICAL, INC. MODEL NUMBER 8200 RESPIRATION/HEART RATE MONITOR 06/05/1987
K872954 AEQUITRON MEDICAL, INC. MODEL NUMBER 9216 RESPIRATION/HEART RATE MONITOR 10/09/1987
K902785 AEQUITRON MEDICAL, INC. MODIFIED MODELS 9500,9550,9200,8200,HEART RATE MON 07/13/1990
K903020 AEQUITRON MEDICAL, INC. RESPIRATION/HEART RATE MONITOR MODEL 9500/9550 04/10/1991
K861743 AIR-SHIELDS, INC. AS165 RESPIRATION MONITOR 05/09/1986
K981728 ALEXANDER MFG. CO. ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER H134 06/26/1998
K852515 ALTERNATIVE DESIGN SYSTEMS, INC. ACCESSORY VENTILLARY(BREATHING) FREQUENCY MONITOR 06/24/1985
K051779 ANDROMED, INC. ANDROFLOW - RESPIRATORY RATE MONITOR 09/30/2005
K870835 APPLIED MEMBRANE TECHNOLOGY, INC. ADULT APNEA MONITOR (20), MONITOR INTERFACE (30) 03/27/1987
K861423 APPLIED MEMBRANE TECHNOLOGY, INC. DEMAND OXYGEN SAVER SYSTEM (D02S) 05/16/1986
K911874 ARECA SCIENCE CORP. SLEEPTRACE 2000 06/25/1992
K891676 ARVEE MEDICAL, INC. ARVEE APNEA MONITOR, MODEL 2400 09/06/1989
K900730 ARVEE MEDICAL, INC. ARVEE APNEA MONITOR, MODEL 4800 06/14/1990
K872631 ARVEE MEDICAL, INC. INFANT MONITOR, MODEL 2400 10/26/1987
K862747 ATLAS RESEARCHES LTD. 8800 SERIES MICRO-PROCESSOR-BASED APNEA MONITORS 08/05/1988
K103631 BIANCAMED LIMITED SLEEPMINDER BREATHING FREQUENCY INDICATOR 07/21/2011
K864261 BIO-DYNE, INC. MODEL 3500 INFANT RESPIRATION & HEART RATE MONITOR 03/27/1987
K930790 BIO-LOGIC SYSTEMS CORP. ADDITION OF BUILT-IN OXYMETER TO SLEEPSCAN PROD. 01/06/1994
K854333 BIOCHEM INTERNATIONAL, INC. BIOCHEM 515 RESPIRATION MONITOR 05/30/1986
K911386 BIOMEDICAL MONITORING SYSTEMS, INC. SLEEPMASTER 04/24/1992
K841392 BIOREC US, INC. BIOMATT-1 01/18/1985
K781515 BOURNS MEDICAL SYSTEMS, INC. MODEL LS-80 ADULT VENTILATION MONITOR 10/02/1978
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
K813507 BRIOX TECHNOLOGIES, INC. INFALERT 01/12/1982
K900264 BUCKMAN CO., INC. R-BAND(TM) RESPIRATORY SENSOR 07/24/1990
K851889 CLINICAL DATA, INC. CENTURION-II, MODEL 3103 APNEA/BRADY CARDIA TRACHY 10/23/1985
K801894 CLINICAL MICROSYSTEMS INTL. RESPONDER II 08/27/1980
K904432 CNS, INC. SLEEP I/T-5 AND SLEEP I/T-8 07/10/1991
K111933 COVIDIEN COVIDIEN NELLCOR RESPIRATION RATE SOFTWARE APPLICATION, VERSION 1.0 03/15/2012
K896934 CREATECH CORP. KNIGHTWATCH SYSTEM 06/25/1990
K861326 DICKSTEIN, SHAPIRO & MORIN RESPISOMNOGRAPH 06/13/1986
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
K844327 EDENTEC CORP. EDENTEC MODEL 2000W APNEA MONITOR 07/15/1985
K921819 EDENTEC CORP. EDENTEC MODEL 3710 I DIGITAL PRINTER 10/22/1993
K913749 EDENTEC CORP. EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170 07/02/1992
K871302 EDENTEC CORP. MODEL 2000W OPTION H CONFIGURATION 04/20/1987
K905575 EDENTEC CORP. MODIFIED MODELS 2000W AND 2000W OPTION H APNEA MON 06/20/1991
K953363 EDENTEC CORP. OXIFLOW DIGITAL RECORDER 02/06/1996
K792528 ELECTRONICS FOR MEDICINE, INC. RESPIRATION/APNEA AMPLIFIER MODEL 3105 02/21/1980
K853252 EMERGENT TECHNOLOGY CORP. EMERGENT TECHNOLOGY VENTILATORY EFFORT MONITOR VEM 01/21/1986
K882377 ENGINEERING DEVELOPMENTS, CO. HEALTH-WATCH BED MONITOR 11/02/1988
K842048 ENSUN MEDICAL PRODUCTS, INC. SUN-ONE 11/01/1984
K941759 EPM DEVELOPMENT SYSTEMS CORP. SNORING SENSOR 11/10/1994
K922112 EPM INFORMATION SYSTEMS, INC. EASYFLOW 12/07/1992
K935518 EPM INFORMATION SYSTEMS, INC. MOVING IMAGES(TM) 05/17/1994
K903300 EPM INFORMATION SYSTEMS, INC. RESP-EZ(TM) RESPIRATORY MONITORING BELT 12/28/1990
K850504 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES COROMETRICS 500 INFANT MONITOR 06/24/1985
K962781 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES COROMETRICS MODEL 510 AND 511 MONITOR 03/06/1997
K873791 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES MODEL 500E INFANT MONITORING SYSTEM 11/23/1987
K943308 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES MODEL 510 INFANT MONITOR 07/25/1995
K942170 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES MODEL 511 INFANT MONITOR 06/02/1995
K861407 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES NEO-TRAK 502 INFANT MONITOR 05/14/1986
K802046 GENERAL ELECTRIC CO. PDS MODEL 3000 ADULT RESPIRATION MODULE 09/16/1980
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
K854355 GREENLEAF SCIENCE CORP. GREENLEAF SMART POLYGRAPH PROGRAM 04/18/1986
K802205 HEALTHDYNE, INC. ECG/RESPIRATION STIMULATOR 10/03/1980
K821731 HEALTHDYNE, INC. HEALTHDYNE MODEL 16900 INFANT MONITOR 07/13/1982
K874814 HEALTHDYNE, INC. HEALTHDYNE RATE METER 02/11/1988
K860254 HEALTHDYNE, INC. HEALTHDYNE'S EVENT RECORDER SYSTEM 01/30/1986
K820645 HEALTHDYNE, INC. INFANT MONITOR 04/15/1982
K861484 HEALTHDYNE, INC. INFANT MONITOR 05/21/1986
K843546 HEALTHDYNE, INC. INFANT MONITOR 16900 10/10/1984
K903287 HEALTHDYNE, INC. MODEL 900S APNEA/HEART MONITOR 08/17/1990
K840488 HEART RATE, INC. LIFECYCLE AEROBIC MONITOR 123 05/30/1984
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
K812667 HONEYWELL, INC. MEDDARS/ULTRA IMAGER RESPIRATION MODULE 10/23/1981
K810175 HONEYWELL, INC. NEO NATAL RESPIRATION FUNCTION BLOCK 03/20/1981
K810174 HONEYWELL, INC. RESPIRATION FUNCTION BLOCKS 03/17/1981
K811014 IMPACT INSTRUMENTATION, INC. RESPIRATORY SENSOR 06/02/1981
K811265 IMPACT INSTRUMENTATION, INC. RESPIRATORY SENSOR (MODEL 409 W/NASOPH.) 06/02/1981
K820778 INTL. MEDICAL DEVICES LTD. RESPIRATION MONITOR 1000 05/03/1982
K820374 JLS GROUP, INC. JLS GROUP INFANT MONITOR 03/26/1982
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
K852249 KONTRON INSTRUMENTS, INC. KONTRON VITALMON 5010 PATIENT MONITOR 10/16/1986
K872833 LADA INTL., INC. BREATHGUARD APNEA MONITOR 04/01/1988
K874898 LIFELINE MEDICAL SYSTEMS, INC. CM 3000 THE MONITOR 03/21/1988
K854705 LIFEWATCH SYSTEMS, INC. INFAGUARD TM 05/01/1986
K864487 LIFEWATCH SYSTEMS, INC. LIFEWATCH SENSOR BELT 01/28/1987
K864419 LIFEWATCH SYSTEMS, INC. LIFEWATCH(R) PORTABLE MONITORING SYSTEM 03/16/1987
K894641 MADAUS MEDTEC, INC. MESAM RECORDER 01/22/1990
K901466 MADAUS MEDTEC, INC. MESAMIV RECORDER 06/08/1990
K900826 MEDICAL SCIENCE PRODUCTS, INC. 'APNEA-ELECTRODE' 04/26/1990
K812873 MEDICON, INC. MEDICON #8200 AMS 11/16/1981
K812045 MEDIX MEDICAL ELECTRONICS (U.S.A.), INC. INFANT APNEA MONITOR MODEL 100 09/24/1981
K812044 MEDIX MEDICAL ELECTRONICS (U.S.A.), INC. RESPIRATION RATE MONITOR 120/121 08/04/1981
K912415 MEDTRONIC VASCULAR MEDICAL SAFETY CABLE AND LEAD SYSTEM 08/16/1991
K925364 MERIT MEDICAL SYSTEMS, INC. MRIDIAN MEDICAL SYSTEMS VENTLATOR HOSES 01/28/1993
K863612 MONAGHAN MEDICAL CORP. MONAGHAN RVM, MODEL 760 AND 761 10/15/1986
K853047 MONAGHAN MEDICAL CORP. MONAGHAN RVM, MODEL 760 OR MODEL 761 11/18/1985
K130570 NEUROVISION MEDICAL PRODUCTS, INC. NEUROVISION MEDICAL MOTION SENSOR 12/26/2013
K891486 NIHON KOHDEN AMERICA, INC. AR-800PA RESPIRATION MODULE 10/24/1989
K823563 NIHON KOHDEN AMERICA, INC. EEG & RESPIRATION MODULES POLYGRAPH 01/12/1983
K862462 NIHON KOHDEN AMERICA, INC. LIFESCOPE 6, OEC-6120 PORTABLE PATIENT MONITOR REC 02/03/1987
K903011 NON-INVASIVE MONITORING SYSTEMS, INC. RESPITRACE PLUS, RESPIBANDS, AND RESPICENTRAL 03/29/1991
K811628 OECO OECO APNEA MONITOR 07/31/1981
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
K860455 OXFORD MEDILOG, INC. MODEL 9000 RECORDING SYSTEM/RESPIRATION MONITORING 04/01/1986
K923737 OXFORD MEDILOG, INC. MODEL MEDILOG RAPIDE 01/05/1994
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
K831650 PLASMEDICS, INC. ANESTHESIA/RESPIRATORY DISCONNECT - 09/12/1983
K831601 PLASMEDICS, INC. APNEA ALARM FOR ADULT-PEDIATRIC & NEON 09/26/1983
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
K923402 PRO-TECH, INC. CRYSTAL TRACE PIEZO RESPIRATORY EFFORT SENSOR 12/30/1992
K940014 PRO-TECH, INC. PLM SENSOR, MODEL PLM1 11/10/1994
K771407 RESEARCH DEVELOPMENT CORP. LUNG VOLUME & PRESSURE MONITOR 08/04/1977
K771019 RESEARCH DEVELOPMENT CORP. LUNG-MECHANICS MONITOR 06/14/1977
K982550 RESPIRONICS, INC. BROWSER (EVENT SOFTWARE) MODEL # 4500E 10/05/1998
K871576 ROKONICS, INC. ROKONICS 8500 07/16/1987
K851819 ROKONICS, INC. ROKONICS SENTRY MODEL 8500 01/21/1986
K884120 S & W MEDICO TEKNIK TYPE 9240 ECG/RESP SYST ATHENA (ADULT & PEDIATIC) 07/17/1990
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
K782045 SCIENTIFIC & GENERAL PTY. LTD. MONITOR HS7 01/10/1979
K782044 SCIENTIFIC & GENERAL PTY. LTD. MONITOR HS8 01/10/1979
K880725 SENTEL TECH. C/O CRITICARE SYSTEMS, INC. SAM(TM) MODEL ONE 09/06/1988
K760339 SHERWOOD MEDICAL INDUSTRIES MONITOR, RESPIRATORY (CPAP) 10/28/1976
K760340 SHERWOOD MEDICAL INDUSTRIES RESPIRATORY SUPPORT SYSTEM, NEONATAL 08/11/1976
K904396 SIMPLEX MEDICAL SYSTEMS, INC. SIMPLEX NEONATAL BREATHING CIRCUIT SYSTEM 03/05/1991
K932902 SPS, INC. MAGNUM 05/10/1994
K770250 SURGIKOS, INC. GOWN, SURGICAL, SURGINE 03/07/1977
K924875 SYNECTICS-DANTEC MICROTRAPPER/MICRODIGITRAPPER, ADD MODIFICATIONS 06/30/1994
K905520 SYNECTICS-DANTEC MICROTRAPPER/MICRODIGITRAPPER, MODIFICATION 04/26/1991
K870661 THE PERKIN-ELMER CORP. LIFEWATCH PLUS 03/09/1987
K781158 THOMPSON RESPIRATION PRODUCTS, INC. ALARM UNIT, BATTERY OPERATED 12/18/1978
K843681 TRI-MED, INC. RESPIRATION & HEART RATE MONITOR 530 12/04/1984
K822819 TRI-MED, INC. TRIMED 510 APNEA MONITOR 11/04/1982
K853452 TRONOMED, INC. LIFE LINC PATIENT CABLE 09/10/1985
K853303 TRONOMED, INC. LIFELINC LEADWIRE 09/18/1985
K883158 VASCUCARE, INC. RESPIRATORY AIRWAY TUBE MONITOR (RATM) 03/06/1989
K811865 VICKERS AMERICA MEDICAL CORP. VMA PEDIATRIC APNEA MATTRESS 07/31/1981
K871813 VITALOG CORP. VITALOG PMS-8 (MODIFICATION) 11/23/1987
K862962 WIRELESS MONITORS, INC. APNET RESPIRATION MONITOR 09/19/1986


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