FDA Product Code
FDA Product Code OLK — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.2700
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K211498 | Nonin OTC Pulse Oximeter Model 3250 | Nonin Medical, Inc. | 2024-11-13 | Traditional | PDF ↗ |
| K214115 | MightySat -OTC | Masimo Corporation | 2024-01-31 | Traditional | PDF ↗ |
Product code OLK · Class II · Cardiovascular. Data: openFDA.