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 |
|---|---|---|---|
| Oct 5, 1998 | K981445 | ULTIMA AIRFLOW SENSOR, 0510 Braebon Medical Corp., CA | BZQ |
| Sep 11, 1998 | K982216 | ULTIMA RESPIRATORY EFFORT SENSOR MODELS 0520 AND 0522 Braebon Medical Corp., CA | BZQ |
| Jun 26, 1998 | K981728 | ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER H134 Alexander Mfg. Co. | BZQ |
| Apr 18, 1997 | K961972 | MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITOR Aequitron Medical, Inc. | BZQ |
| Mar 6, 1997 | K962781 | COROMETRICS MODEL 510 AND 511 MONITOR Ge Medical Systems Information Technologies | BZQ |
| Sep 17, 1996 | K960851 | THERMISTOR CANNULA STYLE,SINGLE ELEMENT,ADAM SHELL THERMISTOR AIRFLOW SENSOR Pro-Tech Services, Inc. | BZQ |
| Feb 6, 1996 | K953363 | OXIFLOW DIGITAL RECORDER Edentec Corp. | BZQ |
| Jul 25, 1995 | K943308 | MODEL 510 INFANT MONITOR Ge Medical Systems Information Technologies | BZQ |
| Jun 2, 1995 | K942170 | MODEL 511 INFANT MONITOR Ge Medical Systems Information Technologies | BZQ |
| Nov 10, 1994 | K941759 | SNORING SENSOR Epm Development Systems Corp. | BZQ |
| Nov 10, 1994 | K940014 | PLM SENSOR, MODEL PLM1 Pro-Tech, Inc. | BZQ |
| Jun 30, 1994 | K924875 | MICROTRAPPER/MICRODIGITRAPPER, ADD MODIFICATIONS Synectics-Dantec | BZQ |
| May 17, 1994 | K935518 | MOVING IMAGES(TM) Epm Information Systems, Inc. | BZQ |
| May 10, 1994 | K932902 | MAGNUM Sps, Inc. | BZQ |
| Jan 6, 1994 | K930790 | ADDITION OF BUILT-IN OXYMETER TO SLEEPSCAN PROD. Bio-Logic Systems Corp. | BZQ |
| Jan 5, 1994 | K923737 | MODEL MEDILOG RAPIDE Oxford Medilog, Inc. | BZQ |
| Oct 22, 1993 | K921819 | EDENTEC MODEL 3710 I DIGITAL PRINTER Edentec Corp. | BZQ |
| Jan 28, 1993 | K925364 | MRIDIAN MEDICAL SYSTEMS VENTLATOR HOSES Merit Medical Systems, Inc. | BZQ |
| Dec 30, 1992 | K923402 | CRYSTAL TRACE PIEZO RESPIRATORY EFFORT SENSOR Pro-Tech, Inc. | BZQ |
| Dec 7, 1992 | K922112 | EASYFLOW Epm Information Systems, Inc. | BZQ |
| Jul 2, 1992 | K913749 | EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170 Edentec Corp. | BZQ |
| Jun 25, 1992 | K911874 | SLEEPTRACE 2000 Areca Science Corp. | BZQ |
| Apr 24, 1992 | K911386 | SLEEPMASTER Biomedical Monitoring Systems, Inc. | BZQ |
| Aug 16, 1991 | K912415 | MEDICAL SAFETY CABLE AND LEAD SYSTEM Medtronic Vascular | BZQ |
| Jul 10, 1991 | K904432 | SLEEP I/T-5 AND SLEEP I/T-8 Cns, Inc. | BZQ |
| Jun 20, 1991 | K905575 | MODIFIED MODELS 2000W AND 2000W OPTION H APNEA MON Edentec Corp. | BZQ |
| Apr 26, 1991 | K905520 | MICROTRAPPER/MICRODIGITRAPPER, MODIFICATION Synectics-Dantec | BZQ |
| Apr 10, 1991 | K903020 | RESPIRATION/HEART RATE MONITOR MODEL 9500/9550 Aequitron Medical, Inc. | BZQ |
| Mar 29, 1991 | K903011 | RESPITRACE PLUS, RESPIBANDS, AND RESPICENTRAL Non-Invasive Monitoring Systems, Inc. | BZQ |
| Mar 5, 1991 | K904396 | SIMPLEX NEONATAL BREATHING CIRCUIT SYSTEM Simplex Medical Systems, Inc. | BZQ |
| Dec 28, 1990 | K903300 | RESP-EZ(TM) RESPIRATORY MONITORING BELT Epm Information Systems, Inc. | BZQ |
| Aug 17, 1990 | K903287 | MODEL 900S APNEA/HEART MONITOR Healthdyne, Inc. | BZQ |
| Jul 24, 1990 | K900264 | R-BAND(TM) RESPIRATORY SENSOR Buckman Co., Inc. | BZQ |
| Jul 17, 1990 | K884120 | TYPE 9240 ECG/RESP SYST ATHENA (ADULT & PEDIATIC) S & W Medico Teknik, DK | BZQ |
| Jul 13, 1990 | K902785 | MODIFIED MODELS 9500,9550,9200,8200,HEART RATE MON Aequitron Medical, Inc. | BZQ |
| Jul 13, 1990 | K901656 | MODEL 9200 RESPIRATION/HEART RATE MONITOR Aequitron Medical, Inc. | BZQ |
| Jun 25, 1990 | K896934 | KNIGHTWATCH SYSTEM Createch Corp. | BZQ |
| Jun 14, 1990 | K900730 | ARVEE APNEA MONITOR, MODEL 4800 Arvee Medical, Inc. | BZQ |
| Jun 8, 1990 | K901466 | MESAMIV RECORDER Madaus Medtec, Inc. | BZQ |
| Apr 26, 1990 | K900826 | 'APNEA-ELECTRODE' Medical Science Products, Inc. | BZQ |
| Jan 22, 1990 | K894641 | MESAM RECORDER Madaus Medtec, Inc. | BZQ |
| Oct 24, 1989 | K891486 | AR-800PA RESPIRATION MODULE Nihon Kohden America, Inc. | BZQ |
| Sep 6, 1989 | K891676 | ARVEE APNEA MONITOR, MODEL 2400 Arvee Medical, Inc. | BZQ |
| Mar 6, 1989 | K883158 | RESPIRATORY AIRWAY TUBE MONITOR (RATM) Vascucare, Inc. | BZQ |
| Jan 30, 1989 | K884637 | MODEL 9550/9500 RESPIRATION/HEART RATE MONITOR Aequitron Medical, Inc. | BZQ |
| Nov 2, 1988 | K882377 | HEALTH-WATCH BED MONITOR Engineering Developments, Co. | BZQ |
| Sep 6, 1988 | K880725 | SAM(TM) MODEL ONE Sentel Tech. C/O Criticare Systems, Inc. | BZQ |
| Aug 5, 1988 | K862747 | 8800 SERIES MICRO-PROCESSOR-BASED APNEA MONITORS Atlas Researches , Ltd., IL | BZQ |
| Jun 10, 1988 | K881266 | MODEL 9216 RESPIRATION/HEART RATE MONITOR Aequitron Medical, Inc. | BZQ |
| Apr 1, 1988 | K872833 | BREATHGUARD APNEA MONITOR Lada Intl., Inc. | BZQ |
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