Panels › Anesthesiology › Product code BTY · Class 2
Calculator, Predicted Values, Pulmonary Function
Regulation 868.1890
1510(k)s in 12 months (64 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
Top companies in BTY
| Company | 510(k)s | Recalls |
|---|---|---|
| Viasys Healthcare GmbH | 5 | 0 |
| Erich Jaeger B.V. | 4 | 0 |
| Medical Graphics Corp. | 4 | 0 |
| Shape Medical Systems, Inc. | 2 | 2 |
| Carefusion Germany 234 GmbH | 3 | 0 |
| Cosmed Srl | 3 | 0 |
| Eresearchtechnology GmbH | 3 | 0 |
| Medical Associated Services, Inc. | 3 | 0 |
| Ndd Medizitechnik AG | 2 | 0 |
| NDDd Medical Technologies, Inc. | 0 | 2 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 15, 2017 | NDDd Medical Technologies, Inc. EasyOne Pro LAB VOS Respiratory Analysis System Pulmonary Function Testing Device, Model 3100-1 Terminated |
BTY | K161534 |
| Aug 15, 2017 | NDDd Medical Technologies, Inc. EasyOne Pro Respiratory Analysis System Pulmonary Function Testing Device, Model 3000-1 Terminated |
BTY | K161534 |
| Feb 5, 2015 | Shape Medical Systems, Inc Shape-HF Cardiopulmonary Testing System Disposable Patient Interface (DPI). Part Number 0004-4001.
The Shape-HF Cardiopulmonary Exercise Testing System is a stationary device that monitors paramet Terminated |
BTY | K090722 |
| Jul 14, 2014 | Shape Medical Systems, Inc Shape HF Cardiopulmonary System. Made up of Shape HF System Analyzer (PN 0001-9001) and Disposable Patient Interface (DPI), (PN 0004-4001). A pulmonary gas exchange testing system used during cardi Terminated |
BTY | K090722 |
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