K232516
- 510(k) number
- K232516
- Device name
- Sentec Digital Monitoring System (SDMS) tCOM+
- Applicant
- Sentec AG CH
- Product code
- LKD — Monitor, Carbon-Dioxide, Cutaneous
- Decision date
- 2024-05-17
- Date received
- 2023-08-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K232516.pdf
Official FDA record: K232516
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.