K211498 is an FDA 510(k) clearance for the Nonin OTC Pulse Oximeter Model 3250. This device is classified as a Pulse Oximeter For Over-the-counter Use (Class II - Special Controls, product code OLK).
Submitted by Nonin Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on November 13, 2024, 1279 days after receiving the submission on May 14, 2021.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700. Non-wearable, Fingertip Pulse Oximeter Intended For Over-the-counter Use For Non-continuous Monitoring.
| 510(k) Number | K211498 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 14, 2021 |
| Decision Date | November 13, 2024 |
| Days to Decision | 1279 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | OLK — Pulse Oximeter For Over-the-counter Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2700 |
| Definition | Non-wearable, Fingertip Pulse Oximeter Intended For Over-the-counter Use For Non-continuous Monitoring |