Panels › Anesthesiology › Product code BZQ · Class 2
Monitor, Breathing Frequency
Regulation 868.2375
2510(k)s in 12 months (176 all time)
0recalls in 12 months (3 all time)
2recalls that name a 510(k)
Top companies in BZQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Aequitron Medical, Inc. | 9 | 0 |
| Earlysense, Ltd. | 8 | 0 |
| Healthdyne, Inc. | 8 | 0 |
| Edentec Corp. | 6 | 0 |
| Ge Medical Systems Information Technologies | 6 | 0 |
| Braebon Medical Corp. | 4 | 0 |
| Arvee Medical, Inc. | 3 | 0 |
| Epm Information Systems, Inc. | 3 | 0 |
| Gereonics, Inc. | 3 | 0 |
| Honeywell, Inc. | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 21, 1988 | K874898 | CM 3000 THE MONITOR Lifeline Medical Systems, Inc. | BZQ |
| Feb 11, 1988 | K874814 | HEALTHDYNE RATE METER Healthdyne, Inc. | BZQ |
| Nov 23, 1987 | K873791 | MODEL 500E INFANT MONITORING SYSTEM Ge Medical Systems Information Technologies | BZQ |
| Nov 23, 1987 | K871813 | VITALOG PMS-8 (MODIFICATION) Vitalog Corp. | BZQ |
| Oct 26, 1987 | K872631 | INFANT MONITOR, MODEL 2400 Arvee Medical, Inc. | BZQ |
| Oct 9, 1987 | K872954 | MODEL NUMBER 9216 RESPIRATION/HEART RATE MONITOR Aequitron Medical, Inc. | BZQ |
| Jul 16, 1987 | K871576 | ROKONICS 8500 Rokonics, Inc. | BZQ |
| Jun 5, 1987 | K871551 | MODEL NUMBER 8200 RESPIRATION/HEART RATE MONITOR Aequitron Medical, Inc. | BZQ |
| Apr 20, 1987 | K871302 | MODEL 2000W OPTION H CONFIGURATION Edentec Corp. | BZQ |
| Mar 27, 1987 | K870835 | ADULT APNEA MONITOR (20), MONITOR INTERFACE (30) Applied Membrane Technology, Inc. | BZQ |
| Mar 27, 1987 | K864261 | MODEL 3500 INFANT RESPIRATION & HEART RATE MONITOR Bio-Dyne, Inc. | BZQ |
| Mar 16, 1987 | K864419 | LIFEWATCH(R) PORTABLE MONITORING SYSTEM Lifewatch Systems, Inc. | BZQ |
| Mar 9, 1987 | K870661 | LIFEWATCH PLUS The Perkin-Elmer Corp. | BZQ |
| Feb 3, 1987 | K862462 | LIFESCOPE 6, OEC-6120 PORTABLE PATIENT MONITOR REC Nihon Kohden America, Inc. | BZQ |
| Jan 28, 1987 | K864487 | LIFEWATCH SENSOR BELT Lifewatch Systems, Inc. | BZQ |
| Oct 16, 1986 | K852249 | KONTRON VITALMON 5010 PATIENT MONITOR Kontron Instruments, Inc. | BZQ |
| Oct 15, 1986 | K863612 | MONAGHAN RVM, MODEL 760 AND 761 Monaghan Medical Corp. | BZQ |
| Sep 19, 1986 | K862962 | APNET RESPIRATION MONITOR Wireless Monitors, Inc. | BZQ |
| Jun 13, 1986 | K861326 | RESPISOMNOGRAPH Dickstein, Shapiro & Morin | BZQ |
| May 30, 1986 | K854333 | BIOCHEM 515 RESPIRATION MONITOR Biochem International, Inc. | BZQ |
| May 21, 1986 | K861484 | INFANT MONITOR Healthdyne, Inc. | BZQ |
| May 16, 1986 | K861423 | DEMAND OXYGEN SAVER SYSTEM (D02S) Applied Membrane Technology, Inc. | BZQ |
| May 14, 1986 | K861407 | NEO-TRAK 502 INFANT MONITOR Ge Medical Systems Information Technologies | BZQ |
| May 9, 1986 | K861743 | AS165 RESPIRATION MONITOR Air-Shields, Inc. | BZQ |
| May 1, 1986 | K854705 | INFAGUARD TM Lifewatch Systems, Inc. | BZQ |
| Apr 18, 1986 | K854355 | GREENLEAF SMART POLYGRAPH PROGRAM Greenleaf Science Corp. | BZQ |
| Apr 1, 1986 | K860455 | MODEL 9000 RECORDING SYSTEM/RESPIRATION MONITORING Oxford Medilog, Inc. | BZQ |
| Jan 30, 1986 | K860254 | HEALTHDYNE'S EVENT RECORDER SYSTEM Healthdyne, Inc. | BZQ |
| Jan 21, 1986 | K853252 | EMERGENT TECHNOLOGY VENTILATORY EFFORT MONITOR VEM Emergent Technology Corp. | BZQ |
| Jan 21, 1986 | K851819 | ROKONICS SENTRY MODEL 8500 Rokonics, Inc. | BZQ |
| Nov 18, 1985 | K853047 | MONAGHAN RVM, MODEL 760 OR MODEL 761 Monaghan Medical Corp. | BZQ |
| Oct 23, 1985 | K851889 | CENTURION-II, MODEL 3103 APNEA/BRADY CARDIA TRACHY Clinical Data, Inc. | BZQ |
| Sep 18, 1985 | K853303 | LIFELINC LEADWIRE Tronomed, Inc. | BZQ |
| Sep 10, 1985 | K853452 | LIFE LINC PATIENT CABLE Tronomed, Inc. | BZQ |
| Aug 2, 1985 | K853084 | MEDICON MODEL 8200 AMS(APNEA MONITOR SYSTEM) Aequitron Medical, Inc. | BZQ |
| Jul 15, 1985 | K844327 | EDENTEC MODEL 2000W APNEA MONITOR Edentec Corp. | BZQ |
| Jun 24, 1985 | K852515 | ACCESSORY VENTILLARY(BREATHING) FREQUENCY MONITOR Alternative Design Systems, Inc. | BZQ |
| Jun 24, 1985 | K850504 | COROMETRICS 500 INFANT MONITOR Ge Medical Systems Information Technologies | BZQ |
| Jan 18, 1985 | K841392 | BIOMATT-1 Biorec Us, Inc. | BZQ |
| Dec 4, 1984 | K843681 | RESPIRATION & HEART RATE MONITOR 530 Tri-Med, Inc. | BZQ |
| Nov 1, 1984 | K842048 | SUN-ONE Ensun Medical Products, Inc. | BZQ |
| Oct 10, 1984 | K843546 | INFANT MONITOR 16900 Healthdyne, Inc. | BZQ |
| May 30, 1984 | K840488 | LIFECYCLE AEROBIC MONITOR 123 Heart Rate, Inc. | BZQ |
| Sep 26, 1983 | K831601 | APNEA ALARM FOR ADULT-PEDIATRIC & NEON Plasmedics, Inc. | BZQ |
| Sep 12, 1983 | K831650 | ANESTHESIA/RESPIRATORY DISCONNECT - Plasmedics, Inc. | BZQ |
| Jan 12, 1983 | K823563 | EEG & RESPIRATION MODULES POLYGRAPH Nihon Kohden America, Inc. | BZQ |
| Nov 4, 1982 | K822819 | TRIMED 510 APNEA MONITOR Tri-Med, Inc. | BZQ |
| Jul 13, 1982 | K821731 | HEALTHDYNE MODEL 16900 INFANT MONITOR Healthdyne, Inc. | BZQ |
| May 3, 1982 | K820778 | RESPIRATION MONITOR 1000 Intl. Medical Devices , Ltd. | BZQ |
| Apr 15, 1982 | K820645 | INFANT MONITOR Healthdyne, Inc. | BZQ |
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