Panels › Anesthesiology › Product code FLS · Class 2
Monitor, Apnea, Facility Use
Regulation 868.2377
0510(k)s in 12 months (16 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in FLS
| Company | 510(k)s | Recalls |
|---|---|---|
| Respironics, Inc. | 0 | 2 |
| Air-Shields, Inc. | 1 | 0 |
| Airsep Corp. | 1 | 0 |
| Alternative Design Systems, Inc. | 1 | 0 |
| Burr Engineering & Development Co. | 1 | 0 |
| Clinical Data, Inc. | 1 | 0 |
| Douglas Scientific Products | 1 | 0 |
| Hogan & Hartson | 1 | 0 |
| Ilife Systems, Inc. | 1 | 0 |
| Litton Medical Electronics | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 19, 2009 | Respironics, Inc. SmartMonitor 2 Infant Apnea Monitor.
The monitor is intended for use in the continuous monitoring of respiration and heart rate of infant patients in a home or hospital environment. The monitor det Terminated |
FLS | K011597 |
| Apr 24, 2008 | Respironics, Inc. Lead Wire Pin/Socket 24 in 1 pr model number 9520. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668. Terminated |
FLS | K011597 |
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