Product Code: BZQ
FDA class 2
21 CFR 868.2375
Monitor, Breathing Frequency
Anesthesiology
The Monitor, Breathing Frequency is a device that continuously measures and displays a patient's respiratory rate, providing clinicians with real-time data on breathing patterns to detect abnormalities such as apnea or tachypnea. It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is BZQ, regulated under 21 CFR 868.2375 in the Anesthesiology specialty. This device is eligible for third-party 510(k) review.
510(k)s
172
FEI Numbers
106
Registration Numbers
106
Unique Applicants
110
Years Active
49
Basic Information
- Product Code
- BZQ
- Device Class
- FDA class 2
- Regulation Number
- 868.2375
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 172 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K243183 | RTM Sense (A-0001) | Jun 27, 2025 | Substantially Equivalent | RTM Vital Signs, LLC |
| K243966 | FaceHeart Vitals Software Development Kit (FH vitals SDK-RR) | Apr 09, 2025 | Substantially Equivalent | FaceHeart Corp. |
| K242001 | Philips VSC-MEDlib | Apr 04, 2025 | Substantially Equivalent | Philips Medical Systems Nederland B.V. |
| K233953 | Makani Science Respiration Monitoring System | Mar 28, 2025 | Substantially Equivalent | Makani Science, Inc. |
| K242798 | Airmod | Feb 28, 2025 | Substantially Equivalent | Heroic Faith International Ltd. |
| K240271 | Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) | Sep 11, 2024 | Substantially Equivalent | Linshom Medical Inc. |
| K223681 | Respiree Cardio-Respiratory Monitor | Mar 08, 2023 | Substantially Equivalent | Respiree PTE Ltd. |
| K221555 | Dozee VS | Dec 15, 2022 | Substantially Equivalent | Turtle Shell Technologies Private Limited |
| K223246 | Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense | Nov 18, 2022 | Substantially Equivalent | Baxter Healthcare Corproration |
| K220111 | RespiraSense | Oct 07, 2022 | Substantially Equivalent | PMD Solutions |
| K211387 | Breathe Easy Mobile Respiratory Monitor (MRM) | Nov 23, 2021 | Substantially Equivalent | Sound Life Sciences, Inc. |
| 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 | Mar 04, 2021 | Substantially Equivalent | Hill-Rom, Inc. |
| K200445 | The C100 Contactless Breathing Monitor | Jun 24, 2020 | Substantially Equivalent | Circadia Technologies Ltd. |
| K190734 | Linshom Respiratory Monitoring Device (LRMD) | Jan 30, 2020 | Substantially Equivalent | Linshom Management LLC |
| K190775 | The RHEA Vital Sign Vigilance System | Dec 19, 2019 | Substantially Equivalent | Shenzhen Fiber Medical Technology Co. Ltd. |
| K173976 | Masimo Acoustic Respiration Sensors, infant and neonate | Sep 05, 2018 | Substantially Equivalent | Masimo Corporation |
| K180079 | Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Activation | May 07, 2018 | Substantially Equivalent | Hill-Rom Inc. |
| K171836 | EarlySense Bed Sensing Unit | Jan 04, 2018 | Substantially Equivalent | EarlySense Ltd. |
| K152911 | EarlySense Insight Sytem | May 06, 2016 | Substantially Equivalent | EarlySense Ltd. |
| K151940 | Thora-3Di, Model T-01 | Mar 10, 2016 | Substantially Equivalent | PneumaCare LIMITED |
| K133661 | CHAIR SENSING UNIT FOR EARLYSENSE SYSTEM | Jun 13, 2014 | Substantially Equivalent | EARLYSENSE LTD. |
| K132320 | INTELLIVUE CL RESPIRATION POD | Mar 26, 2014 | Substantially Equivalent | PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN |
| K130570 | NEUROVISION MEDICAL MOTION SENSOR | Dec 26, 2013 | Substantially Equivalent | NEUROVISION MEDICAL PRODUCTS, INC. |
| K131379 | EARLYSENSE | Dec 18, 2013 | Substantially Equivalent | EARLYSENSE LTD. |
| K122223 | NEW: INTELLIVUE CL RESPIRATION POD NEW: SPECIALIZED ASSESSORY: MOBILE CL RESP ATTACHMENT MODIFIED: INTELLIVUE PATIENT MO | Apr 12, 2013 | Substantially Equivalent | PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH |
| K120465 | EARLYSENSE (EVERON) SYSTEM | Jun 08, 2012 | Substantially Equivalent | EARLYSENSE LTD. |
| K111933 | COVIDIEN NELLCOR RESPIRATION RATE SOFTWARE APPLICATION, VERSION 1.0 | Mar 15, 2012 | Substantially Equivalent | COVIDIEN |
| K103631 | SLEEPMINDER BREATHING FREQUENCY INDICATOR | Jul 21, 2011 | Substantially Equivalent | BIANCAMED LIMITED |
| K100773 | KAI SPOT MODEL KMS 200 | Jun 23, 2010 | Substantially Equivalent | KAI MEDICAL, INC. |
| K092062 | EVERON 1.0 | May 24, 2010 | Substantially Equivalent | EARLYSENSE LTD. |
| K092685 | PNEUMOTHERML, MODEL: 5800 | Nov 24, 2009 | Substantially Equivalent | SALTER LABS |
| K090273 | KAI SENSORS NON-CONTACT RESPIRATORY RATE SPOT CHECK, MODEL 100, KAI RSPOT, MODEL 100 | Jun 05, 2009 | Substantially Equivalent | KAI SENSORS, INC |
| K082465 | EVERON | Mar 25, 2009 | Substantially Equivalent | EARLYSENSE LTD. |
| K080922 | SALTER LABS ORAL/NASAL THERMAL AIRFLOW SENSOR | Jul 25, 2008 | Substantially Equivalent | SALTER LABS, DIVISION OF REGULATORY AFFAIRS |
| K070375 | EARLYSENSE ES-16 SYSTEM | Nov 15, 2007 | Substantially Equivalent | EARLYSENSE LTD. |
| K062883 | GEREONICS ULTRA-PIEZO LIMB MOVEMENT SENSOR | Jun 13, 2007 | Substantially Equivalent | GEREONICS, INC. |
| K051779 | ANDROFLOW - RESPIRATORY RATE MONITOR | Sep 30, 2005 | Substantially Equivalent | ANDROMED, INC. |
| K040605 | DYMEDIX REUSABLE RESPIRATORY EFFORT BELT SENSOR, MODEL 6015 AND DYMEDIX REUSABLE LIMB MOVEMENT SENSOR, MODEL 3100 | Apr 26, 2004 | Substantially Equivalent | DYMEDIX, INC. |
| K003704 | OPTOVENT RESPONS, OPTOVENT RENEE (OPTOVENT RESPONS WITHOUT PULSE OXIMETRY MODULE) | Feb 05, 2001 | Substantially Equivalent | OPTOVENT AB |
| K001743 | ULTIMA SMARTBELT, MODEL 0560 | Aug 25, 2000 | Substantially Equivalent | BRAEBON MEDICAL CORP. |
| K001030 | RESPIRATORY BELT SENSOR, MODEL 6000S; LIMB MOVEMENT SENSOR, MODEL 3000S | May 11, 2000 | Substantially Equivalent | DYMEDIX, INC. |
| K991411 | GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR | Apr 28, 1999 | Substantially Equivalent | GEREONICS, INC. |
| K983449 | GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR | Feb 08, 1999 | Substantially Equivalent | GEREONICS, INC. |
| K981725 | OPTOVENT RESPIRATORY MONITOR MODEL NUMBER RR 9700 | Feb 02, 1999 | Substantially Equivalent | OPTOVENT, INC. |
| K984431 | ULTIMA AIRFLOW PRESSURE SENSOR | Dec 30, 1998 | Substantially Equivalent | BRAEBON MEDICAL CORP. |
| K982550 | BROWSER (EVENT SOFTWARE) MODEL # 4500E | Oct 05, 1998 | Substantially Equivalent - Subject to Tracking Reg. | RESPIRONICS, INC. |
| K981445 | ULTIMA AIRFLOW SENSOR, 0510 | Oct 05, 1998 | Substantially Equivalent | BRAEBON MEDICAL CORP. |
| K982216 | ULTIMA RESPIRATORY EFFORT SENSOR MODELS 0520 AND 0522 | Sep 11, 1998 | Substantially Equivalent | BRAEBON MEDICAL CORP. |
| K981728 | ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER H134 | Jun 26, 1998 | Substantially Equivalent - Subject to Tracking Reg. | ALEXANDER MFG. CO. |
| K961972 | MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITOR | Apr 18, 1997 | Substantially Equivalent - Subject to Tracking Reg. | AEQUITRON MEDICAL, INC. |
| K962781 | COROMETRICS MODEL 510 AND 511 MONITOR | Mar 06, 1997 | Substantially Equivalent - Subject to Tracking Reg. | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
| K960851 | THERMISTOR CANNULA STYLE,SINGLE ELEMENT,ADAM SHELL THERMISTOR AIRFLOW SENSOR | Sep 17, 1996 | Substantially Equivalent - Subject to Tracking Reg. | PRO-TECH SERVICES, INC. |
| K953363 | OXIFLOW DIGITAL RECORDER | Feb 06, 1996 | Substantially Equivalent - Subject to Tracking Reg. | EDENTEC CORP. |
| K943308 | MODEL 510 INFANT MONITOR | Jul 25, 1995 | Substantially Equivalent - Subject to Tracking Reg. | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
| K942170 | MODEL 511 INFANT MONITOR | Jun 02, 1995 | Substantially Equivalent - Subject to Tracking Reg. | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
| K941759 | SNORING SENSOR | Nov 10, 1994 | Substantially Equivalent - Subject to Tracking Reg. | EPM DEVELOPMENT SYSTEMS CORP. |
| K940014 | PLM SENSOR, MODEL PLM1 | Nov 10, 1994 | Substantially Equivalent - Subject to Tracking Reg. | PRO-TECH, INC. |
| K924875 | MICROTRAPPER/MICRODIGITRAPPER, ADD MODIFICATIONS | Jun 30, 1994 | Substantially Equivalent - Subject to Tracking Reg. | SYNECTICS-DANTEC |
| K935518 | MOVING IMAGES(TM) | May 17, 1994 | Substantially Equivalent - Subject to Tracking Reg. | EPM INFORMATION SYSTEMS, INC. |
| K932902 | MAGNUM | May 10, 1994 | Substantially Equivalent - Subject to Tracking Reg. | SPS, INC. |
| K930790 | ADDITION OF BUILT-IN OXYMETER TO SLEEPSCAN PROD. | Jan 06, 1994 | Substantially Equivalent | BIO-LOGIC SYSTEMS CORP. |
| K923737 | MODEL MEDILOG RAPIDE | Jan 05, 1994 | Substantially Equivalent | OXFORD MEDILOG, INC. |
| K921819 | EDENTEC MODEL 3710 I DIGITAL PRINTER | Oct 22, 1993 | Substantially Equivalent | EDENTEC CORP. |
| K925364 | MRIDIAN MEDICAL SYSTEMS VENTLATOR HOSES | Jan 28, 1993 | Substantially Equivalent | MERIT MEDICAL SYSTEMS, INC. |
| K923402 | CRYSTAL TRACE PIEZO RESPIRATORY EFFORT SENSOR | Dec 30, 1992 | Substantially Equivalent | PRO-TECH, INC. |
| K922112 | EASYFLOW | Dec 07, 1992 | Substantially Equivalent | EPM INFORMATION SYSTEMS, INC. |
| K913749 | EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170 | Jul 02, 1992 | Substantially Equivalent | EDENTEC CORP. |
| K911874 | SLEEPTRACE 2000 | Jun 25, 1992 | Substantially Equivalent | ARECA SCIENCE CORP. |
| K911386 | SLEEPMASTER | Apr 24, 1992 | Substantially Equivalent | BIOMEDICAL MONITORING SYSTEMS, INC. |
| K912415 | MEDICAL SAFETY CABLE AND LEAD SYSTEM | Aug 16, 1991 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K904432 | SLEEP I/T-5 AND SLEEP I/T-8 | Jul 10, 1991 | Substantially Equivalent | CNS, INC. |
| K905575 | MODIFIED MODELS 2000W AND 2000W OPTION H APNEA MON | Jun 20, 1991 | Substantially Equivalent | EDENTEC CORP. |
| K905520 | MICROTRAPPER/MICRODIGITRAPPER, MODIFICATION | Apr 26, 1991 | Substantially Equivalent | SYNECTICS-DANTEC |
| K903020 | RESPIRATION/HEART RATE MONITOR MODEL 9500/9550 | Apr 10, 1991 | Substantially Equivalent | AEQUITRON MEDICAL, INC. |
| K903011 | RESPITRACE PLUS, RESPIBANDS, AND RESPICENTRAL | Mar 29, 1991 | Substantially Equivalent | NON-INVASIVE MONITORING SYSTEMS, INC. |
| K904396 | SIMPLEX NEONATAL BREATHING CIRCUIT SYSTEM | Mar 05, 1991 | Substantially Equivalent | SIMPLEX MEDICAL SYSTEMS, INC. |
| K903300 | RESP-EZ(TM) RESPIRATORY MONITORING BELT | Dec 28, 1990 | Substantially Equivalent | EPM INFORMATION SYSTEMS, INC. |
| K903287 | MODEL 900S APNEA/HEART MONITOR | Aug 17, 1990 | Substantially Equivalent | HEALTHDYNE, INC. |
| K900264 | R-BAND(TM) RESPIRATORY SENSOR | Jul 24, 1990 | Substantially Equivalent | BUCKMAN CO., INC. |
| K884120 | TYPE 9240 ECG/RESP SYST ATHENA (ADULT & PEDIATIC) | Jul 17, 1990 | Substantially Equivalent | S & W MEDICO TEKNIK |
| K902785 | MODIFIED MODELS 9500,9550,9200,8200,HEART RATE MON | Jul 13, 1990 | Substantially Equivalent | AEQUITRON MEDICAL, INC. |
| K901656 | MODEL 9200 RESPIRATION/HEART RATE MONITOR | Jul 13, 1990 | Substantially Equivalent | AEQUITRON MEDICAL, INC. |
| K896934 | KNIGHTWATCH SYSTEM | Jun 25, 1990 | Substantially Equivalent | CREATECH CORP. |
| K900730 | ARVEE APNEA MONITOR, MODEL 4800 | Jun 14, 1990 | Substantially Equivalent | ARVEE MEDICAL, INC. |
| K901466 | MESAMIV RECORDER | Jun 08, 1990 | Substantially Equivalent | MADAUS MEDTEC, INC. |
| K900826 | 'APNEA-ELECTRODE' | Apr 26, 1990 | Substantially Equivalent | MEDICAL SCIENCE PRODUCTS, INC. |
| K894641 | MESAM RECORDER | Jan 22, 1990 | Substantially Equivalent | MADAUS MEDTEC, INC. |
| K891486 | AR-800PA RESPIRATION MODULE | Oct 24, 1989 | Substantially Equivalent | NIHON KOHDEN AMERICA, INC. |
| K891676 | ARVEE APNEA MONITOR, MODEL 2400 | Sep 06, 1989 | Substantially Equivalent | ARVEE MEDICAL, INC. |
| K883158 | RESPIRATORY AIRWAY TUBE MONITOR (RATM) | Mar 06, 1989 | Substantially Equivalent | VASCUCARE, INC. |
| K884637 | MODEL 9550/9500 RESPIRATION/HEART RATE MONITOR | Jan 30, 1989 | Substantially Equivalent | AEQUITRON MEDICAL, INC. |
| K882377 | HEALTH-WATCH BED MONITOR | Nov 02, 1988 | Substantially Equivalent | ENGINEERING DEVELOPMENTS, CO. |
| K880725 | SAM(TM) MODEL ONE | Sep 06, 1988 | Substantially Equivalent | SENTEL TECH. C/O CRITICARE SYSTEMS, INC. |
| K862747 | 8800 SERIES MICRO-PROCESSOR-BASED APNEA MONITORS | Aug 05, 1988 | Substantially Equivalent | ATLAS RESEARCHES LTD. |
| K881266 | MODEL 9216 RESPIRATION/HEART RATE MONITOR | Jun 10, 1988 | Substantially Equivalent | AEQUITRON MEDICAL, INC. |
| K872833 | BREATHGUARD APNEA MONITOR | Apr 01, 1988 | Substantially Equivalent | LADA INTL., INC. |
| K874898 | CM 3000 THE MONITOR | Mar 21, 1988 | Substantially Equivalent | LIFELINE MEDICAL SYSTEMS, INC. |
| K874814 | HEALTHDYNE RATE METER | Feb 11, 1988 | Substantially Equivalent | HEALTHDYNE, INC. |
| K873791 | MODEL 500E INFANT MONITORING SYSTEM | Nov 23, 1987 | Substantially Equivalent | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
| K871813 | VITALOG PMS-8 (MODIFICATION) | Nov 23, 1987 | Substantially Equivalent | VITALOG CORP. |
| K872631 | INFANT MONITOR, MODEL 2400 | Oct 26, 1987 | Substantially Equivalent | ARVEE MEDICAL, INC. |
| K872954 | MODEL NUMBER 9216 RESPIRATION/HEART RATE MONITOR | Oct 09, 1987 | Substantially Equivalent | AEQUITRON MEDICAL, INC. |
| K871576 | ROKONICS 8500 | Jul 16, 1987 | Substantially Equivalent | ROKONICS, INC. |
| K871551 | MODEL NUMBER 8200 RESPIRATION/HEART RATE MONITOR | Jun 05, 1987 | Substantially Equivalent | AEQUITRON MEDICAL, INC. |
| K871302 | MODEL 2000W OPTION H CONFIGURATION | Apr 20, 1987 | Substantially Equivalent | EDENTEC CORP. |
| K870835 | ADULT APNEA MONITOR (20), MONITOR INTERFACE (30) | Mar 27, 1987 | Substantially Equivalent | APPLIED MEMBRANE TECHNOLOGY, INC. |
| K864261 | MODEL 3500 INFANT RESPIRATION & HEART RATE MONITOR | Mar 27, 1987 | Substantially Equivalent | BIO-DYNE, INC. |
| K864419 | LIFEWATCH(R) PORTABLE MONITORING SYSTEM | Mar 16, 1987 | Substantially Equivalent | LIFEWATCH SYSTEMS, INC. |
| K870661 | LIFEWATCH PLUS | Mar 09, 1987 | Substantially Equivalent | THE PERKIN-ELMER CORP. |
| K862462 | LIFESCOPE 6, OEC-6120 PORTABLE PATIENT MONITOR REC | Feb 03, 1987 | Substantially Equivalent | NIHON KOHDEN AMERICA, INC. |
| K864487 | LIFEWATCH SENSOR BELT | Jan 28, 1987 | Substantially Equivalent | LIFEWATCH SYSTEMS, INC. |
| K852249 | KONTRON VITALMON 5010 PATIENT MONITOR | Oct 16, 1986 | Substantially Equivalent | KONTRON INSTRUMENTS, INC. |
| K863612 | MONAGHAN RVM, MODEL 760 AND 761 | Oct 15, 1986 | Substantially Equivalent | MONAGHAN MEDICAL CORP. |
| K862962 | APNET RESPIRATION MONITOR | Sep 19, 1986 | Substantially Equivalent | WIRELESS MONITORS, INC. |
| K861326 | RESPISOMNOGRAPH | Jun 13, 1986 | Substantially Equivalent | DICKSTEIN, SHAPIRO & MORIN |
| K854333 | BIOCHEM 515 RESPIRATION MONITOR | May 30, 1986 | Substantially Equivalent | BIOCHEM INTERNATIONAL, INC. |
| K861484 | INFANT MONITOR | May 21, 1986 | Substantially Equivalent | HEALTHDYNE, INC. |
| K861423 | DEMAND OXYGEN SAVER SYSTEM (D02S) | May 16, 1986 | Substantially Equivalent | APPLIED MEMBRANE TECHNOLOGY, INC. |
| K861407 | NEO-TRAK 502 INFANT MONITOR | May 14, 1986 | Substantially Equivalent | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
| K861743 | AS165 RESPIRATION MONITOR | May 09, 1986 | Substantially Equivalent | AIR-SHIELDS, INC. |
| K854705 | INFAGUARD TM | May 01, 1986 | Substantially Equivalent | LIFEWATCH SYSTEMS, INC. |
| K854355 | GREENLEAF SMART POLYGRAPH PROGRAM | Apr 18, 1986 | Substantially Equivalent | GREENLEAF SCIENCE CORP. |
| K860455 | MODEL 9000 RECORDING SYSTEM/RESPIRATION MONITORING | Apr 01, 1986 | Substantially Equivalent | OXFORD MEDILOG, INC. |
| K860254 | HEALTHDYNE'S EVENT RECORDER SYSTEM | Jan 30, 1986 | Substantially Equivalent | HEALTHDYNE, INC. |
| K853252 | EMERGENT TECHNOLOGY VENTILATORY EFFORT MONITOR VEM | Jan 21, 1986 | Substantially Equivalent | EMERGENT TECHNOLOGY CORP. |
| K851819 | ROKONICS SENTRY MODEL 8500 | Jan 21, 1986 | Substantially Equivalent | ROKONICS, INC. |
| K853047 | MONAGHAN RVM, MODEL 760 OR MODEL 761 | Nov 18, 1985 | Substantially Equivalent | MONAGHAN MEDICAL CORP. |
| K851889 | CENTURION-II, MODEL 3103 APNEA/BRADY CARDIA TRACHY | Oct 23, 1985 | Substantially Equivalent | CLINICAL DATA, INC. |
| K853303 | LIFELINC LEADWIRE | Sep 18, 1985 | Substantially Equivalent | TRONOMED, INC. |
| K853452 | LIFE LINC PATIENT CABLE | Sep 10, 1985 | Substantially Equivalent | TRONOMED, INC. |
| K853084 | MEDICON MODEL 8200 AMS(APNEA MONITOR SYSTEM) | Aug 02, 1985 | Substantially Equivalent | AEQUITRON MEDICAL, INC. |
| K844327 | EDENTEC MODEL 2000W APNEA MONITOR | Jul 15, 1985 | Substantially Equivalent | EDENTEC CORP. |
| K852515 | ACCESSORY VENTILLARY(BREATHING) FREQUENCY MONITOR | Jun 24, 1985 | Substantially Equivalent | ALTERNATIVE DESIGN SYSTEMS, INC. |
| K850504 | COROMETRICS 500 INFANT MONITOR | Jun 24, 1985 | Substantially Equivalent | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
| K841392 | BIOMATT-1 | Jan 18, 1985 | Substantially Equivalent | BIOREC US, INC. |
| K843681 | RESPIRATION & HEART RATE MONITOR 530 | Dec 04, 1984 | Substantially Equivalent | TRI-MED, INC. |
| K842048 | SUN-ONE | Nov 01, 1984 | Substantially Equivalent | ENSUN MEDICAL PRODUCTS, INC. |
| K843546 | INFANT MONITOR 16900 | Oct 10, 1984 | Substantially Equivalent | HEALTHDYNE, INC. |
| K840488 | LIFECYCLE AEROBIC MONITOR 123 | May 30, 1984 | Substantially Equivalent | HEART RATE, INC. |
| K831601 | APNEA ALARM FOR ADULT-PEDIATRIC & NEON | Sep 26, 1983 | Substantially Equivalent | PLASMEDICS, INC. |
| K831650 | ANESTHESIA/RESPIRATORY DISCONNECT - | Sep 12, 1983 | Substantially Equivalent | PLASMEDICS, INC. |
| K823563 | EEG & RESPIRATION MODULES POLYGRAPH | Jan 12, 1983 | Substantially Equivalent | NIHON KOHDEN AMERICA, INC. |
| K822819 | TRIMED 510 APNEA MONITOR | Nov 04, 1982 | Substantially Equivalent | TRI-MED, INC. |
| K821731 | HEALTHDYNE MODEL 16900 INFANT MONITOR | Jul 13, 1982 | Substantially Equivalent | HEALTHDYNE, INC. |
| K820778 | RESPIRATION MONITOR 1000 | May 03, 1982 | Substantially Equivalent | INTL. MEDICAL DEVICES LTD. |
| K820645 | INFANT MONITOR | Apr 15, 1982 | Substantially Equivalent | HEALTHDYNE, INC. |
| K820374 | JLS GROUP INFANT MONITOR | Mar 26, 1982 | Substantially Equivalent | JLS GROUP, INC. |
| K813507 | INFALERT | Jan 12, 1982 | Substantially Equivalent | BRIOX TECHNOLOGIES, INC. |
| K812873 | MEDICON #8200 AMS | Nov 16, 1981 | Substantially Equivalent | MEDICON, INC. |
| K812667 | MEDDARS/ULTRA IMAGER RESPIRATION MODULE | Oct 23, 1981 | Substantially Equivalent | HONEYWELL, INC. |
| K812045 | INFANT APNEA MONITOR MODEL 100 | Sep 24, 1981 | Substantially Equivalent | MEDIX MEDICAL ELECTRONICS (U.S.A.), INC. |
| K812044 | RESPIRATION RATE MONITOR 120/121 | Aug 04, 1981 | Substantially Equivalent | MEDIX MEDICAL ELECTRONICS (U.S.A.), INC. |
| K811865 | VMA PEDIATRIC APNEA MATTRESS | Jul 31, 1981 | Substantially Equivalent | VICKERS AMERICA MEDICAL CORP. |
| K811628 | OECO APNEA MONITOR | Jul 31, 1981 | Substantially Equivalent | OECO |
| K811265 | RESPIRATORY SENSOR (MODEL 409 W/NASOPH.) | Jun 02, 1981 | Substantially Equivalent | IMPACT INSTRUMENTATION, INC. |
| K811014 | RESPIRATORY SENSOR | Jun 02, 1981 | Substantially Equivalent | IMPACT INSTRUMENTATION, INC. |
| K810175 | NEO NATAL RESPIRATION FUNCTION BLOCK | Mar 20, 1981 | Substantially Equivalent | HONEYWELL, INC. |
| K810174 | RESPIRATION FUNCTION BLOCKS | Mar 17, 1981 | Substantially Equivalent | HONEYWELL, INC. |
| K802205 | ECG/RESPIRATION STIMULATOR | Oct 03, 1980 | Substantially Equivalent | HEALTHDYNE, INC. |
| K802046 | PDS MODEL 3000 ADULT RESPIRATION MODULE | Sep 16, 1980 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K801894 | RESPONDER II | Aug 27, 1980 | Substantially Equivalent | CLINICAL MICROSYSTEMS INTL. |
| K792528 | RESPIRATION/APNEA AMPLIFIER MODEL 3105 | Feb 21, 1980 | Substantially Equivalent | ELECTRONICS FOR MEDICINE, INC. |
| K790304 | PREAMPLIFIER MODULE, EKG RESPIRATION | Feb 27, 1979 | Substantially Equivalent | ABBOTT MEDICAL ELECTRONICS CO. |
| K782045 | MONITOR HS7 | Jan 10, 1979 | Substantially Equivalent | SCIENTIFIC & GENERAL PTY. LTD. |
| K782044 | MONITOR HS8 | Jan 10, 1979 | Substantially Equivalent | SCIENTIFIC & GENERAL PTY. LTD. |
| K781158 | ALARM UNIT, BATTERY OPERATED | Dec 18, 1978 | Substantially Equivalent | THOMPSON RESPIRATION PRODUCTS, INC. |
| K781515 | MODEL LS-80 ADULT VENTILATION MONITOR | Oct 02, 1978 | Substantially Equivalent | BOURNS MEDICAL SYSTEMS, INC. |
| K771407 | LUNG VOLUME & PRESSURE MONITOR | Aug 04, 1977 | Substantially Equivalent | RESEARCH DEVELOPMENT CORP. |
| K771019 | LUNG-MECHANICS MONITOR | Jun 14, 1977 | Substantially Equivalent | RESEARCH DEVELOPMENT CORP. |
| K770250 | GOWN, SURGICAL, SURGINE | Mar 07, 1977 | Substantially Equivalent | SURGIKOS, INC. |
| K760339 | MONITOR, RESPIRATORY (CPAP) | Oct 28, 1976 | Substantially Equivalent | SHERWOOD MEDICAL INDUSTRIES |
| K760340 | RESPIRATORY SUPPORT SYSTEM, NEONATAL | Aug 11, 1976 | Substantially Equivalent | SHERWOOD MEDICAL INDUSTRIES |
FEI Numbers
This FDA classification entry is associated with 106 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 106 registration numbers. Click on an entry to view related FDA registrations.