K214115 is an FDA 510(k) clearance for the MightySat -OTC. This device is classified as a Pulse Oximeter For Over-the-counter Use (Class II - Special Controls, product code OLK).
Submitted by Masimo Corporation (Irvine, US). The FDA issued a Cleared decision on January 31, 2024, 762 days after receiving the submission on December 30, 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 | K214115 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 30, 2021 |
| Decision Date | January 31, 2024 |
| Days to Decision | 762 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 |