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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 8, 2024 | Vyaire Medical, Inc. Vyaire Medical GmbH, Vyaire Twin Tube sample line 240 cm, Model Number V-707327; The TwinTube sample line 240cm is used in the Vyntus CPX. The TwinTube sample line 240cm is connected to the adapter fo Open, Classified |
BZC | K150810 |
| Sep 8, 2016 | Innovision A/S Innocor Cardiopulmonary Exercise and Lung Function Testing System
Non-invasive diagnostic device that measures or calculates a number of hemodynamic and metabolic parameters. Terminated |
BZC | K102047 |
| Apr 8, 2010 | Philips Healthcare Inc. REFURBISHED TIDALWAVE SP 710, REFURBISHED, Respironics/Philips product.
Intended use of the monitors is to provide short term monitoring of carbon dioxide and oxygen saturation during anesthesia/reco Terminated |
BZC | K963380 |
| Apr 8, 2010 | Philips Healthcare Inc. Spanish 100-120V Cosmo Plus 8100, Respironics/Philips product.
Used to provide spirometric, carbon dioxide and pulse oximetry monitoring. Terminated |
BZC | K963380 |
| Apr 8, 2010 | Philips Healthcare Inc. Resp Profile Monitor, 8100 Cosmo+, Respironics/Philips product.
Used to provide spirometric, carbon dioxide and pulse oximetry monitoring. Terminated |
BZC | K963380 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.