Panels › Anesthesiology › Product code KLK · Class 2
Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
Regulation 868.2500
0510(k)s in 12 months (47 all time)
0recalls in 12 months (3 all time)
1recalls that name a 510(k)
Top companies in KLK
| Company | 510(k)s | Recalls |
|---|---|---|
| Novametrix Medical Systems, Inc. | 13 | 0 |
| Biochem International, Inc. | 3 | 0 |
| Radiometer America Inc | 0 | 3 |
| Critikon Company, LLC | 2 | 0 |
| Ge Medical Systems Information Technologies | 2 | 0 |
| Hewlett-Packard Co. | 2 | 0 |
| Instrumentation Laboratory CO | 2 | 0 |
| Linde Medical Sensors AG | 2 | 0 |
| Mennen Medical, Inc. | 2 | 0 |
| Sumitomo Electric Industries, Inc. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 31, 2006 | Radiometer America Inc D826 Accessory kit for single tcpO2 Electrodes for use with the TCM400 Transcutaneous Monitor (Cutaneous Oxygen Monitor) Terminated |
KLK | K001866 |
| Aug 30, 2006 | Radiometer America Inc TC Monitor - Transcutaneous Monitor for p02 and pC02, Model #TCM4, (Cutaneous Oxygen Monitor) Terminated |
KLK | None listed |
| Aug 29, 2006 | Radiometer America Inc TCM4 Series Monitoring System (Base Unit) 391-876 (affected device) CompactFlash cards: 914-698 (Defective Device Component) Terminated |
KLK | None listed |
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