Sentec Digital Monitoring System (SDMS) tCOM+
FDA 510(k) clearance K232516 · decided 2024-05-17
Clearance details
- K-number
- K232516
- Device name
- Sentec Digital Monitoring System (SDMS) tCOM+
- Applicant
- Sentec AG
- Decision
- Substantially Equivalent
- Date received
- 2023-08-18
- Decision date
- 2024-05-17
- Days to decision
- 273 days
- Clearance type
- Traditional
- Product code
- LKD
- Device class
- 2
- Regulation number
- 868.2480
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Therwil, CH
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Sentec AG
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.