K101690 is an FDA 510(k) clearance for the SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLE. This device is classified as a Monitor, Carbon-dioxide, Cutaneous (Class II - Special Controls, product code LKD).
Submitted by Sentec AG (Egale, US). The FDA issued a Cleared decision on December 3, 2010, 170 days after receiving the submission on June 16, 2010.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2480.
| 510(k) Number | K101690 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 16, 2010 |
| Decision Date | December 03, 2010 |
| Days to Decision | 170 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | LKD - Monitor, Carbon-dioxide, Cutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.2480 |