K232516 is an FDA 510(k) clearance for the Sentec Digital Monitoring System (SDMS) tCOM+. 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 May 17, 2024, 273 days after receiving the submission on August 18, 2023.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2480.
| 510(k) Number | K232516 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 18, 2023 |
| Decision Date | May 17, 2024 |
| Days to Decision | 273 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 |