Product code BZC
- Device name
- Calculator, Pulmonary Function Data
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.1880
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K240293 | STS | Techbopulm, Ltd. | 2024-09-17 |
| K183567 | Vyntus/SentrySuite Product Line | Vyaire Medical | 2019-08-23 |
| K190853 | Vyntus BODY | Vyaire Medical, Inc. | 2019-08-16 |
| K181524 | Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART | Vyaire Medical, Inc. | 2018-11-30 |
| K162515 | COSMED K5 Wearable Metabolic Technology | Cosmed Srl | 2017-06-20 |
| K161295 | MiniBox + | Pulmone Advanced Medical Devices, Ltd. | 2016-10-21 |
| K150810 | Vyntus / SentrySuite Product Line | Carefusion Germany 234 GmbH | 2015-08-14 |
| K133925 | VYNTUS/ SENTRYSUITE PRODUCT LINE | Carefusion Germany 234 GmbH | 2014-08-22 |
| K133051 | PULMONE MINIBOX PFT TM | Pulmone Advanced Medical Devices, Ltd. | 2014-05-02 |
| K102047 | LCI OPTION FOR INNOCOR | Innovision A/S | 2011-11-01 |
| K072323 | MASTERSCREEN & OXYCON CPX | Viasys Healthcare GmbH | 2007-10-10 |
| K052328 | ZAN LUNG-FUNCTION LAB | Zan Messgerate GmbH | 2005-12-22 |
| K040698 | MASTERSCREEN CPX AND OXYCON CPX | Viasys Healthcare GmbH | 2004-04-07 |
| K023120 | OXYCON MOBILE | Erich Jaeger GmbH | 2003-11-12 |
| K011344 | INFANT PLETHYSMOGRAPH, MODEL 004400; PEDIATRIC PLETHYSMOGRAPH, MODEL 004400 | Collins Medical, Inc. | 2002-05-17 |
| K001631 | CORTEX METAMAX | Cortex Biophysik GmbH | 2001-02-22 |
| K001174 | COSMED QUARK | Cosmed Srl | 2001-01-11 |
| K001502 | AEROSOL PROVOCATION SYSTEM APS PRO, MODEL APS PRO | Erich Jaeger GmbH | 2000-07-12 |
| K992214 | OXYCON PRO | Erich Jaeger B.V. | 2000-02-22 |
| K982499 | COSMO PLUS WITH NICO, MODEL 8200 | Novametrix Medical Systems, Inc. | 1998-10-16 |
| K982487 | CPT, INC. METEOR HAND HELD RESPIRATORY MECHANICS MONITOR METEOR 100, CPT, INC. METEOR HAND HELD RESPIRATORY MECHANICS MO | Cardiopulmonary Technologies, Inc. | 1998-10-14 |
| K970840 | INTELLIFLOW RESPIRATORY ANALYZER | Simtec, Inc. | 1997-11-26 |
| K963373 | COSMED K4 | Cosmed Srl | 1997-09-10 |
| K964360 | VENT(VENTCHECK) HANDHELD RESPIRATORY/MECHANICS MONITOR MODEL 101 | Novametrix Medical Systems, Inc. | 1997-04-04 |
| K954730 | BENCHMARK TRANSFER TEST | P.K. Morgan , Ltd. | 1997-04-01 |
| K964939 | THE PORTABLE FAMILY - MEDI-FACTS DX1 PORTABLE LITE AND DX1 PORTABLE PLUS | Creative Biomedics, Inc. | 1997-03-06 |
| K963380 | CO 2 SMO PLUS | Novametrix Medical Systems, Inc. | 1997-01-22 |
| K960121 | AUTOLINK BODY PLETHYSMOGRAPH | P.K. Morgan , Ltd. | 1997-01-09 |
| K953990 | TRANSFLOW TEST | P.K. Morgan , Ltd. | 1996-12-09 |
| K960831 | VENTRAK RMMS 1550 | Novametrix Medical Systems, Inc. | 1996-05-29 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04250892908816 | Jaeger | Jaeger Medical GmbH | 2025-11-24 |
| 14250892908905 | Jaeger | Jaeger Medical GmbH | 2025-11-24 |
| 04250892908809 | Jaeger | Jaeger Medical GmbH | 2025-10-31 |
| 04250892908793 | Jaeger | Jaeger Medical GmbH | 2025-10-31 |
| 04250892908786 | Jaeger | Jaeger Medical GmbH | 2025-10-31 |
| 04250892908779 | Jaeger | Jaeger Medical GmbH | 2025-10-31 |
| 04250892908427 | Jaeger | Jaeger Medical GmbH | 2025-10-31 |
| 04250892908328 | Jaeger | Jaeger Medical GmbH | 2025-10-31 |
| 34250892908367 | Jaeger | Jaeger Medical GmbH | 2025-10-31 |
| 34250892908541 | Jaeger | Jaeger Medical GmbH | 2025-10-31 |
| 34250892908589 | Jaeger | Jaeger Medical GmbH | 2025-10-31 |
| 04250892908311 | Jaeger | Jaeger Medical GmbH | 2025-10-31 |
| 04250892908304 | Jaeger | Jaeger Medical GmbH | 2025-10-31 |
| 04250892907345 | Jaeger | Jaeger Medical GmbH | 2025-10-31 |
| 14250892907052 | Jaeger | Jaeger Medical GmbH | 2025-08-14 |
| 14250892907069 | Jaeger | Jaeger Medical GmbH | 2025-08-14 |
| 14250892907045 | Jaeger | Jaeger Medical GmbH | 2025-08-14 |
| 14250892907519 | Jaeger | Jaeger Medical GmbH | 2025-07-23 |
| 14250892908066 | Jaeger | Jaeger Medical GmbH | 2025-06-02 |
| 04250892904726 | Vyntus | VYAIRE MEDICAL, INC. | 2021-04-09 |
| 34250892904970 | Vyntus | VYAIRE MEDICAL, INC. | 2021-04-09 |
| 00810016250340 | MGC Diagnostics | MEDICAL GRAPHICS CORPORATION | 2019-02-22 |
| 00884838020849 | SO2 Optical Module | Philips Medizin Systeme Böblingen GmbH | 2018-12-18 |
| 00853452007024 | FUTUREMED | FUTUREMED AMERICA, INC. | 2017-10-24 |
| B23133151 | Metaphor Flow Sensor | TREYMED INC | 2017-09-27 |
| B23133141 | Metaphor Flow Sensor | TREYMED INC | 2017-09-27 |
| B23133131 | Metaphor Flow Sensor | TREYMED INC | 2017-09-27 |
| B23133121 | Metaphor Flow Sensor | TREYMED INC | 2017-09-27 |
| 20884838072248 | Spirometry Sensor | Philips Medizin Systeme Böblingen GmbH | 2017-01-20 |
| 18052400180034 | COSMED | C O S M E D SRL | 2016-09-23 |