BZQ · Monitor, Breathing Frequency
Anesthesiology · 21 CFR 868.2375 · Class 2
Overview
| Product Code | BZQ |
|---|---|
| Device Name | Monitor, Breathing Frequency |
| Regulation | 21 CFR 868.2375 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 3rd-Party Reviewable | Yes |
Identification
A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.
Classification Rationale
Class II (performance standards).
Cleared Devices (174)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250093 | Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) | Linshom Medical, Inc. | Sep 26, 2025 | SESE |
| K250934 | Respiree Cardio- Respiratory Monitor System | Respiree Pte, Ltd. | Aug 5, 2025 | SESE |
| K243183 | RTMsense Respiratory Monitoring System | Rtm Vital Signs, LLC | Jun 27, 2025 | SESE |
| K243966 | FaceHeart Vitals Software Development Kit (FH vitals SDK-RR) | Faceheart Corp. | Apr 9, 2025 | SESE |
| K242001 | Philips VSC-MEDlib | Philips Medical Systems Nederland B.V. | Apr 4, 2025 | SESE |
| K233953 | Makani Science Respiration Monitoring System | Makani Science, Inc. | Mar 28, 2025 | SESE |
| K242798 | Airmod | Heroic Faith International , Ltd. | Feb 28, 2025 | SESE |
| K240271 | Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) | Linshom Medical, Inc. | Sep 11, 2024 | SESE |
| K223681 | Respiree Cardio-Respiratory Monitor | Respiree Pte, Ltd. | Mar 8, 2023 | SESE |
| K221555 | Dozee VS | Turtle Shell Technologies Private Limited | Dec 15, 2022 | SESE |
| K223246 | Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense | Baxter Healthcare Corproration | Nov 18, 2022 | SESE |
| K220111 | RespiraSense | Pmd Solutions | Oct 7, 2022 | SESE |
| K211387 | Breathe Easy Mobile Respiratory Monitor (MRM) | Sound Life Sciences, Inc. | Nov 23, 2021 | SESE |
| K202018 | 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 | Hill-Rom, Inc. | Mar 4, 2021 | SESE |
| K200445 | The C100 Contactless Breathing Monitor | Circadia Technologies, Ltd. | Jun 24, 2020 | SESE |
| K190734 | Linshom Respiratory Monitoring Device (LRMD) | Linshom Management, LLC | Jan 30, 2020 | SESE |
| K190775 | The RHEA Vital Sign Vigilance System | Shenzhen Fiber Medical Technology Co. , Ltd. | Dec 19, 2019 | SESE |
| K173976 | Masimo Acoustic Respiration Sensors, infant and neonate | Masimo Corporation | Sep 5, 2018 | SESE |
| K180079 | Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Activation | Hill-Rom, Inc. | May 7, 2018 | SESE |
| K171836 | EarlySense Bed Sensing Unit | Earlysense, Ltd. | Jan 4, 2018 | SESE |
| K152911 | EarlySense Insight Sytem | Earlysense, Ltd. | May 6, 2016 | SESE |
| K151940 | Thora-3Di, Model T-01 | Pneumacare Limited | Mar 10, 2016 | SESE |
| K133661 | CHAIR SENSING UNIT FOR EARLYSENSE SYSTEM | Earlysense, Ltd. | Jun 13, 2014 | SESE |
| K132320 | INTELLIVUE CL RESPIRATION POD | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | Mar 26, 2014 | SESE |
| K130570 | NEUROVISION MEDICAL MOTION SENSOR | Neurovision Medical Products, Inc. | Dec 26, 2013 | SESE |
| K131379 | EARLYSENSE | Earlysense, Ltd. | Dec 18, 2013 | SESE |
| K122223 | NEW: INTELLIVUE CL RESPIRATION POD NEW: SPECIALIZED ASSESSORY: MOBILE CL RESP ATTACHMENT MODIFIED: INTELLIVUE PATIENT MO | Philips Medizin Systeme Boeblingen GmbH | Apr 12, 2013 | SESE |
| K120465 | EARLYSENSE (EVERON) SYSTEM | Earlysense, Ltd. | Jun 8, 2012 | SESE |
| K111933 | COVIDIEN NELLCOR RESPIRATION RATE SOFTWARE APPLICATION, VERSION 1.0 | Covidien | Mar 15, 2012 | SESE |
| K103631 | SLEEPMINDER BREATHING FREQUENCY INDICATOR | Biancamed Limited | Jul 21, 2011 | SESE |
| K100773 | KAI SPOT MODEL KMS 200 | Kai Medical, Inc. | Jun 23, 2010 | SESE |
| K092062 | EVERON 1.0 | Earlysense, Ltd. | May 24, 2010 | SESE |
| K092685 | PNEUMOTHERML, MODEL: 5800 | Salter Labs | Nov 24, 2009 | SESE |
| K090273 | KAI SENSORS NON-CONTACT RESPIRATORY RATE SPOT CHECK, MODEL 100, KAI RSPOT, MODEL 100 | Kai Sensors, Inc. | Jun 5, 2009 | SESE |
| K082465 | EVERON | Earlysense, Ltd. | Mar 25, 2009 | SESE |
| K080922 | SALTER LABS ORAL/NASAL THERMAL AIRFLOW SENSOR | Salter Labs, Division of Regulatory Affairs | Jul 25, 2008 | SESE |
| K070375 | EARLYSENSE ES-16 SYSTEM | Earlysense, Ltd. | Nov 15, 2007 | SESE |
| K062883 | GEREONICS ULTRA-PIEZO LIMB MOVEMENT SENSOR | Gereonics, Inc. | Jun 13, 2007 | SESE |
| K051779 | ANDROFLOW - RESPIRATORY RATE MONITOR | Andromed, Inc. | Sep 30, 2005 | SESE |
| K040605 | DYMEDIX REUSABLE RESPIRATORY EFFORT BELT SENSOR, MODEL 6015 AND DYMEDIX REUSABLE LIMB MOVEMENT SENSOR, MODEL 3100 | Dymedix, Inc. | Apr 26, 2004 | SESE |
| K003704 | OPTOVENT RESPONS, OPTOVENT RENEE (OPTOVENT RESPONS WITHOUT PULSE OXIMETRY MODULE) | Optovent AB | Feb 5, 2001 | SESE |
| K001743 | ULTIMA SMARTBELT, MODEL 0560 | Braebon Medical Corp. | Aug 25, 2000 | SESE |
| K001030 | RESPIRATORY BELT SENSOR, MODEL 6000S; LIMB MOVEMENT SENSOR, MODEL 3000S | Dymedix, Inc. | May 11, 2000 | SESE |
| K991411 | GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR | Gereonics, Inc. | Apr 28, 1999 | SESE |
| K983449 | GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR | Gereonics, Inc. | Feb 8, 1999 | SESE |
| K981725 | OPTOVENT RESPIRATORY MONITOR MODEL NUMBER RR 9700 | Optovent, Inc. | Feb 2, 1999 | SESE |
| K984431 | ULTIMA AIRFLOW PRESSURE SENSOR | Braebon Medical Corp. | Dec 30, 1998 | SESE |
| K982550 | BROWSER (EVENT SOFTWARE) MODEL # 4500E | Respironics, Inc. | Oct 5, 1998 | ST |
| K981445 | ULTIMA AIRFLOW SENSOR, 0510 | Braebon Medical Corp. | Oct 5, 1998 | SESE |
| K982216 | ULTIMA RESPIRATORY EFFORT SENSOR MODELS 0520 AND 0522 | Braebon Medical Corp. | Sep 11, 1998 | SESE |
| K981728 | ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER H134 | Alexander Mfg. Co. | Jun 26, 1998 | ST |
| K961972 | MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITOR | Aequitron Medical, Inc. | Apr 18, 1997 | ST |
| K962781 | COROMETRICS MODEL 510 AND 511 MONITOR | Ge Medical Systems Information Technologies | Mar 6, 1997 | ST |
| K960851 | THERMISTOR CANNULA STYLE,SINGLE ELEMENT,ADAM SHELL THERMISTOR AIRFLOW SENSOR | Pro-Tech Services, Inc. | Sep 17, 1996 | ST |
| K953363 | OXIFLOW DIGITAL RECORDER | Edentec Corp. | Feb 6, 1996 | ST |
| K943308 | MODEL 510 INFANT MONITOR | Ge Medical Systems Information Technologies | Jul 25, 1995 | ST |
| K942170 | MODEL 511 INFANT MONITOR | Ge Medical Systems Information Technologies | Jun 2, 1995 | ST |
| K941759 | SNORING SENSOR | Epm Development Systems Corp. | Nov 10, 1994 | ST |
| K940014 | PLM SENSOR, MODEL PLM1 | Pro-Tech, Inc. | Nov 10, 1994 | ST |
| K924875 | MICROTRAPPER/MICRODIGITRAPPER, ADD MODIFICATIONS | Synectics-Dantec | Jun 30, 1994 | ST |
| K935518 | MOVING IMAGES(TM) | Epm Information Systems, Inc. | May 17, 1994 | ST |
| K932902 | MAGNUM | Sps, Inc. | May 10, 1994 | ST |
| K930790 | ADDITION OF BUILT-IN OXYMETER TO SLEEPSCAN PROD. | Bio-Logic Systems Corp. | Jan 6, 1994 | SESE |
| K923737 | MODEL MEDILOG RAPIDE | Oxford Medilog, Inc. | Jan 5, 1994 | SESE |
| K921819 | EDENTEC MODEL 3710 I DIGITAL PRINTER | Edentec Corp. | Oct 22, 1993 | SESE |
| K925364 | MRIDIAN MEDICAL SYSTEMS VENTLATOR HOSES | Merit Medical Systems, Inc. | Jan 28, 1993 | SESE |
| K923402 | CRYSTAL TRACE PIEZO RESPIRATORY EFFORT SENSOR | Pro-Tech, Inc. | Dec 30, 1992 | SESE |
| K922112 | EASYFLOW | Epm Information Systems, Inc. | Dec 7, 1992 | SESE |
| K913749 | EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170 | Edentec Corp. | Jul 2, 1992 | SESE |
| K911874 | SLEEPTRACE 2000 | Areca Science Corp. | Jun 25, 1992 | SESE |
| K911386 | SLEEPMASTER | Biomedical Monitoring Systems, Inc. | Apr 24, 1992 | SESE |
| K912415 | MEDICAL SAFETY CABLE AND LEAD SYSTEM | Medtronic Vascular | Aug 16, 1991 | SESE |
| K904432 | SLEEP I/T-5 AND SLEEP I/T-8 | Cns, Inc. | Jul 10, 1991 | SESE |
| K905575 | MODIFIED MODELS 2000W AND 2000W OPTION H APNEA MON | Edentec Corp. | Jun 20, 1991 | SESE |
| K905520 | MICROTRAPPER/MICRODIGITRAPPER, MODIFICATION | Synectics-Dantec | Apr 26, 1991 | SESE |
| K903020 | RESPIRATION/HEART RATE MONITOR MODEL 9500/9550 | Aequitron Medical, Inc. | Apr 10, 1991 | SESE |
| K903011 | RESPITRACE PLUS, RESPIBANDS, AND RESPICENTRAL | Non-Invasive Monitoring Systems, Inc. | Mar 29, 1991 | SESE |
| K904396 | SIMPLEX NEONATAL BREATHING CIRCUIT SYSTEM | Simplex Medical Systems, Inc. | Mar 5, 1991 | SESE |
| K903300 | RESP-EZ(TM) RESPIRATORY MONITORING BELT | Epm Information Systems, Inc. | Dec 28, 1990 | SESE |
| K903287 | MODEL 900S APNEA/HEART MONITOR | Healthdyne, Inc. | Aug 17, 1990 | SESE |
| K900264 | R-BAND(TM) RESPIRATORY SENSOR | Buckman Co., Inc. | Jul 24, 1990 | SESE |
| K884120 | TYPE 9240 ECG/RESP SYST ATHENA (ADULT & PEDIATIC) | S & W Medico Teknik | Jul 17, 1990 | SESE |
| K902785 | MODIFIED MODELS 9500,9550,9200,8200,HEART RATE MON | Aequitron Medical, Inc. | Jul 13, 1990 | SESE |
| K901656 | MODEL 9200 RESPIRATION/HEART RATE MONITOR | Aequitron Medical, Inc. | Jul 13, 1990 | SESE |
| K896934 | KNIGHTWATCH SYSTEM | Createch Corp. | Jun 25, 1990 | SESE |
| K900730 | ARVEE APNEA MONITOR, MODEL 4800 | Arvee Medical, Inc. | Jun 14, 1990 | SESE |
| K901466 | MESAMIV RECORDER | Madaus Medtec, Inc. | Jun 8, 1990 | SESE |
| K900826 | 'APNEA-ELECTRODE' | Medical Science Products, Inc. | Apr 26, 1990 | SESE |
| K894641 | MESAM RECORDER | Madaus Medtec, Inc. | Jan 22, 1990 | SESE |
| K891486 | AR-800PA RESPIRATION MODULE | Nihon Kohden America, Inc. | Oct 24, 1989 | SESE |
| K891676 | ARVEE APNEA MONITOR, MODEL 2400 | Arvee Medical, Inc. | Sep 6, 1989 | SESE |
| K883158 | RESPIRATORY AIRWAY TUBE MONITOR (RATM) | Vascucare, Inc. | Mar 6, 1989 | SESE |
| K884637 | MODEL 9550/9500 RESPIRATION/HEART RATE MONITOR | Aequitron Medical, Inc. | Jan 30, 1989 | SESE |
| K882377 | HEALTH-WATCH BED MONITOR | Engineering Developments, Co. | Nov 2, 1988 | SESE |
| K880725 | SAM(TM) MODEL ONE | Sentel Tech. C/O Criticare Systems, Inc. | Sep 6, 1988 | SESE |
| K862747 | 8800 SERIES MICRO-PROCESSOR-BASED APNEA MONITORS | Atlas Researches , Ltd. | Aug 5, 1988 | SESE |
| K881266 | MODEL 9216 RESPIRATION/HEART RATE MONITOR | Aequitron Medical, Inc. | Jun 10, 1988 | SESE |
| K872833 | BREATHGUARD APNEA MONITOR | Lada Intl., Inc. | Apr 1, 1988 | SESE |
| K874898 | CM 3000 THE MONITOR | Lifeline Medical Systems, Inc. | Mar 21, 1988 | SESE |
| K874814 | HEALTHDYNE RATE METER | Healthdyne, Inc. | Feb 11, 1988 | SESE |
| K873791 | MODEL 500E INFANT MONITORING SYSTEM | Ge Medical Systems Information Technologies | Nov 23, 1987 | SESE |
| K871813 | VITALOG PMS-8 (MODIFICATION) | Vitalog Corp. | Nov 23, 1987 | SESE |
| K872631 | INFANT MONITOR, MODEL 2400 | Arvee Medical, Inc. | Oct 26, 1987 | SESE |
| K872954 | MODEL NUMBER 9216 RESPIRATION/HEART RATE MONITOR | Aequitron Medical, Inc. | Oct 9, 1987 | SESE |
| K871576 | ROKONICS 8500 | Rokonics, Inc. | Jul 16, 1987 | SESE |
| K871551 | MODEL NUMBER 8200 RESPIRATION/HEART RATE MONITOR | Aequitron Medical, Inc. | Jun 5, 1987 | SESE |
| K871302 | MODEL 2000W OPTION H CONFIGURATION | Edentec Corp. | Apr 20, 1987 | SESE |
| K870835 | ADULT APNEA MONITOR (20), MONITOR INTERFACE (30) | Applied Membrane Technology, Inc. | Mar 27, 1987 | SESE |
| K864261 | MODEL 3500 INFANT RESPIRATION & HEART RATE MONITOR | Bio-Dyne, Inc. | Mar 27, 1987 | SESE |
| K864419 | LIFEWATCH(R) PORTABLE MONITORING SYSTEM | Lifewatch Systems, Inc. | Mar 16, 1987 | SESE |
| K870661 | LIFEWATCH PLUS | The Perkin-Elmer Corp. | Mar 9, 1987 | SESE |
| K862462 | LIFESCOPE 6, OEC-6120 PORTABLE PATIENT MONITOR REC | Nihon Kohden America, Inc. | Feb 3, 1987 | SESE |
| K864487 | LIFEWATCH SENSOR BELT | Lifewatch Systems, Inc. | Jan 28, 1987 | SESE |
| K852249 | KONTRON VITALMON 5010 PATIENT MONITOR | Kontron Instruments, Inc. | Oct 16, 1986 | SESE |
| K863612 | MONAGHAN RVM, MODEL 760 AND 761 | Monaghan Medical Corp. | Oct 15, 1986 | SESE |
| K862962 | APNET RESPIRATION MONITOR | Wireless Monitors, Inc. | Sep 19, 1986 | SESE |
| K861326 | RESPISOMNOGRAPH | Dickstein, Shapiro & Morin | Jun 13, 1986 | SESE |
| K854333 | BIOCHEM 515 RESPIRATION MONITOR | Biochem International, Inc. | May 30, 1986 | SESE |
| K861484 | INFANT MONITOR | Healthdyne, Inc. | May 21, 1986 | SESE |
| K861423 | DEMAND OXYGEN SAVER SYSTEM (D02S) | Applied Membrane Technology, Inc. | May 16, 1986 | SESE |
| K861407 | NEO-TRAK 502 INFANT MONITOR | Ge Medical Systems Information Technologies | May 14, 1986 | SESE |
| K861743 | AS165 RESPIRATION MONITOR | Air-Shields, Inc. | May 9, 1986 | SESE |
| K854705 | INFAGUARD TM | Lifewatch Systems, Inc. | May 1, 1986 | SESE |
| K854355 | GREENLEAF SMART POLYGRAPH PROGRAM | Greenleaf Science Corp. | Apr 18, 1986 | SESE |
| K860455 | MODEL 9000 RECORDING SYSTEM/RESPIRATION MONITORING | Oxford Medilog, Inc. | Apr 1, 1986 | SESE |
| K860254 | HEALTHDYNE'S EVENT RECORDER SYSTEM | Healthdyne, Inc. | Jan 30, 1986 | SESE |
| K853252 | EMERGENT TECHNOLOGY VENTILATORY EFFORT MONITOR VEM | Emergent Technology Corp. | Jan 21, 1986 | SESE |
| K851819 | ROKONICS SENTRY MODEL 8500 | Rokonics, Inc. | Jan 21, 1986 | SESE |
| K853047 | MONAGHAN RVM, MODEL 760 OR MODEL 761 | Monaghan Medical Corp. | Nov 18, 1985 | SESE |
| K851889 | CENTURION-II, MODEL 3103 APNEA/BRADY CARDIA TRACHY | Clinical Data, Inc. | Oct 23, 1985 | SESE |
| K853303 | LIFELINC LEADWIRE | Tronomed, Inc. | Sep 18, 1985 | SESE |
| K853452 | LIFE LINC PATIENT CABLE | Tronomed, Inc. | Sep 10, 1985 | SESE |
| K853084 | MEDICON MODEL 8200 AMS(APNEA MONITOR SYSTEM) | Aequitron Medical, Inc. | Aug 2, 1985 | SESE |
| K844327 | EDENTEC MODEL 2000W APNEA MONITOR | Edentec Corp. | Jul 15, 1985 | SESE |
| K852515 | ACCESSORY VENTILLARY(BREATHING) FREQUENCY MONITOR | Alternative Design Systems, Inc. | Jun 24, 1985 | SESE |
| K850504 | COROMETRICS 500 INFANT MONITOR | Ge Medical Systems Information Technologies | Jun 24, 1985 | SESE |
| K841392 | BIOMATT-1 | Biorec Us, Inc. | Jan 18, 1985 | SESE |
| K843681 | RESPIRATION & HEART RATE MONITOR 530 | Tri-Med, Inc. | Dec 4, 1984 | SESE |
| K842048 | SUN-ONE | Ensun Medical Products, Inc. | Nov 1, 1984 | SESE |
| K843546 | INFANT MONITOR 16900 | Healthdyne, Inc. | Oct 10, 1984 | SESE |
| K840488 | LIFECYCLE AEROBIC MONITOR 123 | Heart Rate, Inc. | May 30, 1984 | SESE |
| K831601 | APNEA ALARM FOR ADULT-PEDIATRIC & NEON | Plasmedics, Inc. | Sep 26, 1983 | SESE |
| K831650 | ANESTHESIA/RESPIRATORY DISCONNECT - | Plasmedics, Inc. | Sep 12, 1983 | SESE |
| K823563 | EEG & RESPIRATION MODULES POLYGRAPH | Nihon Kohden America, Inc. | Jan 12, 1983 | SESE |
| K822819 | TRIMED 510 APNEA MONITOR | Tri-Med, Inc. | Nov 4, 1982 | SESE |
| K821731 | HEALTHDYNE MODEL 16900 INFANT MONITOR | Healthdyne, Inc. | Jul 13, 1982 | SESE |
| K820778 | RESPIRATION MONITOR 1000 | Intl. Medical Devices , Ltd. | May 3, 1982 | SESE |
| K820645 | INFANT MONITOR | Healthdyne, Inc. | Apr 15, 1982 | SESE |
| K820374 | JLS GROUP INFANT MONITOR | Jls Group, Inc. | Mar 26, 1982 | SESE |
| K813507 | INFALERT | Briox Technologies, Inc. | Jan 12, 1982 | SESE |
| K812873 | MEDICON #8200 AMS | Medicon, Inc. | Nov 16, 1981 | SESE |
| K812667 | MEDDARS/ULTRA IMAGER RESPIRATION MODULE | Honeywell, Inc. | Oct 23, 1981 | SESE |
| K812045 | INFANT APNEA MONITOR MODEL 100 | Medix Medical Electronics (U.S.A.), Inc. | Sep 24, 1981 | SESE |
| K812044 | RESPIRATION RATE MONITOR 120/121 | Medix Medical Electronics (U.S.A.), Inc. | Aug 4, 1981 | SESE |
| K811865 | VMA PEDIATRIC APNEA MATTRESS | Vickers America Medical Corp. | Jul 31, 1981 | SESE |
| K811628 | OECO APNEA MONITOR | Oeco | Jul 31, 1981 | SESE |
| K811265 | RESPIRATORY SENSOR (MODEL 409 W/NASOPH.) | Impact Instrumentation, Inc. | Jun 2, 1981 | SESE |
| K811014 | RESPIRATORY SENSOR | Impact Instrumentation, Inc. | Jun 2, 1981 | SESE |
| K810175 | NEO NATAL RESPIRATION FUNCTION BLOCK | Honeywell, Inc. | Mar 20, 1981 | SESE |
| K810174 | RESPIRATION FUNCTION BLOCKS | Honeywell, Inc. | Mar 17, 1981 | SESE |
| K802205 | ECG/RESPIRATION STIMULATOR | Healthdyne, Inc. | Oct 3, 1980 | SESE |
| K802046 | PDS MODEL 3000 ADULT RESPIRATION MODULE | General Electric Co. | Sep 16, 1980 | SESE |
| K801894 | RESPONDER II | Clinical Microsystems Intl. | Aug 27, 1980 | SESE |
| K792528 | RESPIRATION/APNEA AMPLIFIER MODEL 3105 | Electronics For Medicine, Inc. | Feb 21, 1980 | SESE |
| K790304 | PREAMPLIFIER MODULE, EKG RESPIRATION | Abbott Medical Electronics Co. | Feb 27, 1979 | SESE |
| K782045 | MONITOR HS7 | Scientific & General Pty. , Ltd. | Jan 10, 1979 | SESE |
| K782044 | MONITOR HS8 | Scientific & General Pty. , Ltd. | Jan 10, 1979 | SESE |
| K781158 | ALARM UNIT, BATTERY OPERATED | Thompson Respiration Products, Inc. | Dec 18, 1978 | SESE |
| K781515 | MODEL LS-80 ADULT VENTILATION MONITOR | Bourns Medical Systems, Inc. | Oct 2, 1978 | SESE |
| K771407 | LUNG VOLUME & PRESSURE MONITOR | Research Development Corp. | Aug 4, 1977 | SESE |
| K771019 | LUNG-MECHANICS MONITOR | Research Development Corp. | Jun 14, 1977 | SESE |
| K770250 | GOWN, SURGICAL, SURGINE | Surgikos, Inc. | Mar 7, 1977 | SESE |
| K760339 | MONITOR, RESPIRATORY (CPAP) | Sherwood Medical Industries | Oct 28, 1976 | SESE |
| K760340 | RESPIRATORY SUPPORT SYSTEM, NEONATAL | Sherwood Medical Industries | Aug 11, 1976 | SESE |
Top Applicants
- Aequitron Medical, Inc. — 9 clearances
- Healthdyne, Inc. — 8 clearances
- Earlysense, Ltd. — 8 clearances
- Ge Medical Systems Information Technologies — 6 clearances
- Edentec Corp. — 6 clearances
