Panels › Anesthesiology › Product code NPF · Class 2
Monitor, Apnea, Home Use
Regulation 868.2377
0510(k)s in 12 months (2 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in NPF
| Company | 510(k)s | Recalls |
|---|---|---|
| Respironics, Inc. | 2 | 2 |
| Childrens Medical Ventures | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 13, 2014 | Childrens Medical Ventures Philips/Children's Medical Ventures Smart Monitor 2 Professional Series infant apnea monitor. Terminated |
NPF | K061256 |
| Apr 24, 2008 | Respironics, Inc. Oximeter Patient Cable Masimo 8 ft model number H5870. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668. Terminated |
NPF | K032403 |
| Apr 24, 2008 | Respironics, Inc. APNEA monitor accessories under the following brand names: a) SM 2 PS/PSL, Prof. Operators Manual, NL-NL model number 1025422; b) SM 2/2 PS Europe Patient Cable, Metal model number 1030194; and c) Sma Terminated |
NPF | K061256 |
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