OLK
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Pulse Oximeter For Over-The-Counter Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2700
- Medical specialty
- Cardiovascular
- FDA definition
- Non-wearable, fingertip pulse oximeter intended for over-the-counter use for non-continuous monitoring
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Nonin OTC Pulse Oximeter Model 3250 (K211498) | Nonin Medical, Inc. | 2024-11-13 |
| MightySat -OTC (K214115) | Masimo Corporation | 2024-01-31 |
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