K212876 is an FDA 510(k) clearance for the Carescape SpO2 - Masimo. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Masimo Corporation (Irvine, US). The FDA issued a Cleared decision on October 8, 2021, 29 days after receiving the submission on September 9, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K212876 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 09, 2021 |
| Decision Date | October 08, 2021 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQA — Oximeter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2700 |