Panels › Anesthesiology › Product code CBK · Class 2
Ventilator, Continuous, Facility Use
Regulation 868.5895
4510(k)s in 12 months (505 all time)
23recalls in 12 months (336 all time)
306recalls that name a 510(k)
Top companies in CBK
| Company | 510(k)s | Recalls |
|---|---|---|
| Hamilton Medical AG | 35 | 31 |
| Philips Respironics | 0 | 54 |
| Draeger Medical AG & Co. KG | 14 | 26 |
| Puritan Bennett Corp. | 34 | 1 |
| Newport Medical Instruments, Inc. | 17 | 12 |
| Respironics, Inc. | 14 | 14 |
| Covidien | 4 | 23 |
| Bird Products Corp. | 21 | 0 |
| Respironics California, Inc. | 8 | 13 |
| Bio-Med Devices, Inc. | 9 | 8 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 4, 1998 | K980642 | EVITA 4 (8411900) Drager, Inc. | CBK |
| Aug 24, 1998 | K981971 | TBIRD VS/AVS VOLUME VENTILATOR, MODELS 15568, 15570 , LP10 VOLUME VENTILATOR WITH PRESSURE LIMIT MODEL 00-004130, BEAR 3 Bird Products Corp. | CBK |
| Aug 4, 1998 | K980208 | DIVAN ANESTHESIA VENTILATOR Draeger Medical, Inc. | CBK |
| Jun 24, 1998 | K982174 | VENTURI VENTILATOR Cardiopulmonary Corp. | CBK |
| Jun 17, 1998 | K974176 | BABYLOG 8000 PLUS Drager, Inc. | CBK |
| Apr 30, 1998 | K970460 | NELLCOR PURITAN BENNETT, 840 VENTILATOR SYSTEM (MODEL 840) Puritan Bennett Corp. | CBK |
| Apr 28, 1998 | K970158 | BABYPAC Pneupac, Inc. | CBK |
| Nov 14, 1997 | K964540 | NELLCOR PURITAN BENNETT, 740 VENTILATOR SYSTEM Puritan Bennett Corp. | CBK |
| Nov 6, 1997 | K972203 | BABYBIRD VENTILATOR, PORTABLE LIFECARE VENTILATOR, EXTERNAL PRESSURE LIMITER, VOLUME VENTILATOR WITH PRESSURE LIMIT Allied Healthcare Products, Inc. | CBK |
| Oct 14, 1997 | K970839 | SERVO VENTILATOR 300A Siemens Elema AB, SE | CBK |
| Sep 12, 1997 | K972248 | NELLCOR PURITAN BENNETT GEMINI Nellcor Puritan Bennett, Inc. | CBK |
| Aug 26, 1997 | K970165 | EVITA 2 DURA Drager, Inc. | CBK |
| Feb 14, 1997 | K964543 | INFRASONICS ADULT VENTILATOR TRENDING OPTION Nellcor Puritan Bennett, Inc. | CBK |
| Dec 13, 1996 | K961687 | EVITA 4 Drager, Inc. | CBK |
| Nov 5, 1996 | K950853 | OPTIONAL DISPLAY AND SOFTWARE FOR DRAGER VENTILATORS Drager, Inc. | CBK |
| Oct 25, 1996 | K960168 | SIEMENS SERVO SCREEN 390 AND SERVO COMPUTER MODULE 990 Siemens Elema AB | CBK |
| Oct 25, 1996 | K960010 | SERVO VENTILATOR 300 COMPUTER INTERFACE Siemens Elema AB | CBK |
| Sep 27, 1996 | K960964 | OHMEDA 7900 ANESTHESIA VENTILATOR Ohmeda Medical | CBK |
| Sep 16, 1996 | K953238 | DRAGER MICRO VENT Drager, Inc. | CBK |
| Aug 19, 1996 | K960861 | OMICRON MONITOR, DELTA MONITOR Core-M, Inc. | CBK |
| Aug 6, 1996 | K955865 | BEAR CUB INFANT PRESSURE VENTILATOR Allied Healthcare Products, Inc. | CBK |
| Jun 20, 1996 | K952880 | MODEL LP-1000 VOLUME VENTILATOR Aequitron Medical, Inc. | CBK |
| May 3, 1996 | K950484 | TBIRD VS VENTILATOR AND TBIRD AVS VENTILATOR Bird Products Corp. | CBK |
| Mar 1, 1996 | K953228 | NARKOMED AV2+ ANESTHESIA VENTILATOR Draeger Medical, Inc. | CBK |
| Dec 28, 1995 | K943106 | ADULT VENTILATOR Infrasonics Corp. | CBK |
| Oct 16, 1995 | K943412 | VENTURI VENTILATOR Cardiopulmonary Corp. | CBK |
| Sep 19, 1995 | K942938 | CROSSVENT-4 VENTILATOR Bio-Med Devices, Inc. | CBK |
| Aug 25, 1995 | K943531 | OXYLOG 2000 Drager, Inc. | CBK |
| Aug 25, 1995 | K941308 | NEWPORT ELECTRONIC MANOMETER Newport Medical Instruments, Inc. | CBK |
| Mar 6, 1995 | K941309 | NEWPORT ELECTRONIC MANOMETER Newport Medical Instruments, Inc. | CBK |
| Sep 22, 1994 | K930017 | PB 7200 SERIES VENTILATORY SYSTEM W/KEYBOARD Puritan Bennett Corp. | CBK |
| Sep 22, 1994 | K924043 | AUTO-PEEP Puritan Bennett Corp. | CBK |
| Sep 22, 1994 | K922975 | MODEL 7200AE VENTILATOR (ENHANCEMENT) Puritan Bennett Corp. | CBK |
| Sep 22, 1994 | K922705 | MODEL 7200AE VENTILATOR Puritan Bennett Corp. | CBK |
| Sep 15, 1994 | K922102 | PROPORTIONAL SOLENOID VALVE Puritan Bennett Corp. | CBK |
| Apr 19, 1994 | K926292 | BABYLOG 8000 INFANT VENTILATOR Drager, Inc. | CBK |
| Feb 15, 1994 | K930747 | BIRD 8400TI ADULT VOLUME VENTILATOR Bird Products Corp. | CBK |
| Jan 10, 1994 | K924930 | EVITA Drager, Inc. | CBK |
| Jul 29, 1993 | K933262 | BIRD AVIAN PORT MILITARY VENT NSN 6530-01-374-8903 Bird Products Corp. | CBK |
| Apr 13, 1993 | K923992 | POWER PACK 350/BATTERY PACK 351 Siemens Medical Solutions USA, Inc. | CBK |
| Mar 11, 1993 | K921387 | BIRD 8400ST ADULT VOLUME VENTILATOR Bird Products Corp. | CBK |
| Mar 5, 1993 | K923444 | SERVO GRAPHICS Siemens Medical Solutions USA, Inc. | CBK |
| Feb 19, 1993 | K920113 | BIRD GRAPHICS MONITOR Bird Products Corp. | CBK |
| Feb 1, 1993 | K920121 | SECHRIST IV-100B SAVI SYSTEM Sechrist | CBK |
| Jan 22, 1993 | K925262 | MERIDIAN MEDICAL SYSTEMS VOLUME VENTILATOR CIRCUIT Merit Medical Systems, Inc. | CBK |
| Dec 17, 1992 | K922314 | VENTILATOR INTERFACE 9291/4 S & W Medico Teknik, DK | CBK |
| Dec 1, 1992 | K922654 | VENTILATOR ADULT STAR MODIFICATION Infrasonics Corp. | CBK |
| Nov 10, 1992 | K920002 | MODEL 7200AE VENTILATOR FLOW BY 2.0 OR OPTION 50 Puritan Bennett Corp. | CBK |
| Nov 2, 1992 | K921821 | IBT MODEL SVI Biomagnetic Technologies, Inc. | CBK |
| Nov 2, 1992 | K914607 | SEHRIST VOLUME VENTILATOR, MODEL 2200B Sechrist Industries, Inc. | CBK |
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