K223651 is an FDA 510(k) clearance for the Cerebral Adaptive Index (CAI) Algorithm. This device is classified as a Oximeter, Tissue Saturation (Class II - Special Controls, product code MUD).
Submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on May 26, 2023, 171 days after receiving the submission on December 6, 2022.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K223651 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 06, 2022 |
| Decision Date | May 26, 2023 |
| Days to Decision | 171 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | MUD — Oximeter, Tissue Saturation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2700 |