LKD
- Product code
- LKD
- Device name
- Monitor, Carbon-Dioxide, Cutaneous
- Device class
- Class 2
- 21 CFR
- 21 CFR 868.2480
- Medical specialty
- Anesthesiology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 1
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 17 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K232516 | 2024-05-17 | Sentec AG | Sentec Digital Monitoring System (SDMS) tCOM+ |
Official FDA classification page: LKD
Classification and pathway per current FDA publications. Data from openFDA (CC0).