Panels › Anesthesiology › Product code BWF · Class 2
Spirometer, Therapeutic (Incentive)
Regulation 868.5690
0510(k)s in 12 months (108 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in BWF
| Company | 510(k)s | Recalls |
|---|---|---|
| Dhd Healthcare Corp. | 5 | 0 |
| Dhd Medical Products Div. Diemolding Corp. | 4 | 0 |
| Health Products, Inc. | 4 | 0 |
| Advanced Circulatory Systems, Inc. | 3 | 0 |
| Chesebrough-Pond'S U.S.A. Co. | 3 | 0 |
| Dhd Diemolding Healthcare Div. | 3 | 0 |
| Trudell Medical International | 3 | 0 |
| Airlife, Inc. | 2 | 0 |
| Besmed Health Business Corp | 2 | 0 |
| D R Burton Healthcare, LLC | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 21, 2020 | Smiths Medical ASD Inc. Portex Acapella DH Vibratory PEP Device - Product Usage: a single patient use device that provides Positive Expiratory Pressure (PEP) Therapy for patients who have Cystic Fibrosis, COPD, asthma, and l Terminated |
BWF | K002768 |
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