Panels › Anesthesiology › Product code BZC · Class 2
Calculator, Pulmonary Function Data
Regulation 868.1880
0510(k)s in 12 months (90 all time)
0recalls in 12 months (5 all time)
5recalls that name a 510(k)
Top companies in BZC
| Company | 510(k)s | Recalls |
|---|---|---|
| Erich Jaeger B.V. | 8 | 0 |
| Novametrix Medical Systems, Inc. | 4 | 0 |
| Vyaire Medical | 3 | 1 |
| Warren E. Collins, Inc. | 4 | 0 |
| Cardio Pulmonary Instruments | 3 | 0 |
| Cosmed Srl | 3 | 0 |
| Cybermedic, Inc. | 3 | 0 |
| P.K. Morgan , Ltd. | 3 | 0 |
| Philips Healthcare Inc. | 0 | 3 |
| Pulmonary Testing Systems | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 17, 2024 | K240293 | STS Techbopulm, Ltd., IL | BZC |
| Aug 23, 2019 | K183567 | Vyntus/SentrySuite Product Line Vyaire Medical, DE | BZC |
| Aug 16, 2019 | K190853 | Vyntus BODY Vyaire Medical, Inc. | BZC |
| Nov 30, 2018 | K181524 | Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustabl Vyaire Medical, Inc., DE | BZC |
| Jun 20, 2017 | K162515 | COSMED K5 Wearable Metabolic Technology Cosmed Srl, IT | BZC |
| Oct 21, 2016 | K161295 | MiniBox + Pulmone Advanced Medical Devices, Ltd., IL | BZC |
| Aug 14, 2015 | K150810 | Vyntus / SentrySuite Product Line Carefusion Germany 234 GmbH, DE | BZC |
| Aug 22, 2014 | K133925 | VYNTUS/ SENTRYSUITE PRODUCT LINE Carefusion Germany 234 GmbH, DE | BZC |
| May 2, 2014 | K133051 | PULMONE MINIBOX PFT TM Pulmone Advanced Medical Devices, Ltd. | BZC |
| Nov 1, 2011 | K102047 | LCI OPTION FOR INNOCOR Innovision A/S | BZC |
| Oct 10, 2007 | K072323 | MASTERSCREEN & OXYCON CPX Viasys Healthcare GmbH | BZC |
| Dec 22, 2005 | K052328 | ZAN LUNG-FUNCTION LAB Zan Messgerate GmbH | BZC |
| Apr 7, 2004 | K040698 | MASTERSCREEN CPX AND OXYCON CPX Viasys Healthcare GmbH | BZC |
| Nov 12, 2003 | K023120 | OXYCON MOBILE Erich Jaeger GmbH | BZC |
| May 17, 2002 | K011344 | INFANT PLETHYSMOGRAPH, MODEL 004400; PEDIATRIC PLETHYSMOGRAPH, MODEL 004400 Collins Medical, Inc. | BZC |
| Feb 22, 2001 | K001631 | CORTEX METAMAX Cortex Biophysik GmbH | BZC |
| Jan 11, 2001 | K001174 | COSMED QUARK Cosmed Srl | BZC |
| Jul 12, 2000 | K001502 | AEROSOL PROVOCATION SYSTEM APS PRO, MODEL APS PRO Erich Jaeger GmbH | BZC |
| Feb 22, 2000 | K992214 | OXYCON PRO Erich Jaeger B.V., NL | BZC |
| Oct 16, 1998 | K982499 | COSMO PLUS WITH NICO, MODEL 8200 Novametrix Medical Systems, Inc. | BZC |
| Oct 14, 1998 | K982487 | CPT, INC. METEOR HAND HELD RESPIRATORY MECHANICS MONITOR METEOR 100, CPT, INC. METEOR HAND HELD RESPIRATORY MECHANICS MO Cardiopulmonary Technologies, Inc. | BZC |
| Nov 26, 1997 | K970840 | INTELLIFLOW RESPIRATORY ANALYZER Simtec, Inc. | BZC |
| Sep 10, 1997 | K963373 | COSMED K4 Cosmed Srl | BZC |
| Apr 4, 1997 | K964360 | VENT(VENTCHECK) HANDHELD RESPIRATORY/MECHANICS MONITOR MODEL 101 Novametrix Medical Systems, Inc. | BZC |
| Apr 1, 1997 | K954730 | BENCHMARK TRANSFER TEST P.K. Morgan , Ltd., GB | BZC |
| Mar 6, 1997 | K964939 | THE PORTABLE FAMILY - MEDI-FACTS DX1 PORTABLE LITE AND DX1 PORTABLE PLUS Creative Biomedics, Inc. | BZC |
| Jan 22, 1997 | K963380 | CO 2 SMO PLUS Novametrix Medical Systems, Inc. | BZC |
| Jan 9, 1997 | K960121 | AUTOLINK BODY PLETHYSMOGRAPH P.K. Morgan , Ltd., GB | BZC |
| Dec 9, 1996 | K953990 | TRANSFLOW TEST P.K. Morgan , Ltd., GB | BZC |
| May 29, 1996 | K960831 | VENTRAK RMMS 1550 Novametrix Medical Systems, Inc. | BZC |
| Apr 23, 1996 | K952542 | ACKRAD ESOPHAGEAL BALLOON CATHETER SET Ackrad Laboratories | BZC |
| Sep 15, 1995 | K946077 | DIRECTIONAL CONTROL VALVES INFLATABLE BALLOON-TYPE AND CONTROLLERS Hans Rudolph, Inc. | BZC |
| Aug 11, 1995 | K951157 | DX1-PORTABLE Creative Biomedics, Inc. | BZC |
| Jun 16, 1995 | K941843 | MMS-2400 Parvo Medics, Inc. | BZC |
| May 25, 1995 | K945213 | TEEN 100 Aerosport, Inc. | BZC |
| Mar 3, 1995 | K942864 | LUNG DIFFUSION Nordan Smith Welding Supplies | BZC |
| Sep 27, 1994 | K935309 | LUNG DIFFUSION Acetylene Gas Co. | BZC |
| Jun 25, 1993 | K921306 | ARGIS PULMONARY FUNCTION TESTING SYSTEM Med Science | BZC |
| Dec 2, 1992 | K915833 | SENSORMEDICS MODEL 2600 PEDIATRIC PULMOONARY CART Sensor Medics Corp. | BZC |
| Dec 1, 1992 | K915686 | MODEL 2900 METABOLIC MEASUREMENT CART Sensor Medics Corp. | BZC |
| Jul 2, 1992 | K913681 | MULTISPIRO-BREEZE Multispiro, Inc. | BZC |
| May 6, 1991 | K905480 | SPIROSCOPE Grandcor Medical Systems | BZC |
| Nov 29, 1990 | K900696 | BIORE CP-100 CARDIOPULMONARY MONITOR Bicore Monitoring Systems | BZC |
| Mar 16, 1990 | K895963 | MODIFIED STAR CALC Infrasonics Corp. | BZC |
| Oct 27, 1989 | K893845 | PEDS WATER FILLED CATHETER/TRANSDUCER SYSTEM Medical Associated Services, Inc. | BZC |
| Oct 24, 1989 | K894839 | OS-1 OCCLUSION SYSTEM - 1 Medical, Inc. | BZC |
| Sep 22, 1989 | K892670 | PHYSIO-DYNE EASI (EASY ANALOG SAMPLING INTERFACE) Physio-Dyne Instrument Corp. | BZC |
| Jun 16, 1989 | K892121 | SPIRO-LINK REAL TIME SPIROMETRY SYSTEM Biocom Intl., Inc. | BZC |
| Mar 31, 1989 | K881235 | Q-PLEX 1 Quinton, Inc. | BZC |
| Mar 9, 1989 | K883732 | ARGIS PULMONARY FUNCTION TESTING SYSTEM Advanced Signal Processing, Inc. | BZC |
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