K151329 is an FDA 510(k) clearance for the SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet. This device is classified as a Monitor, Carbon-dioxide, Cutaneous (Class II - Special Controls, product code LKD).
Submitted by Sentec AG (Therwil, CH). The FDA issued a Cleared decision on December 17, 2015, 213 days after receiving the submission on May 18, 2015.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2480.
| 510(k) Number | K151329 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 18, 2015 |
| Decision Date | December 17, 2015 |
| Days to Decision | 213 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 |