K240596 is an FDA 510(k) clearance for the Cerebral Autoregulation Index (CAI) Algorithm. This device is classified as a Oximeter, Tissue Saturation (Class II - Special Controls, product code MUD).
Submitted by Edwards Lifesciences (Irvine, US). The FDA issued a Cleared decision on October 16, 2024, 226 days after receiving the submission on March 4, 2024.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K240596 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 04, 2024 |
| Decision Date | October 16, 2024 |
| Days to Decision | 226 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 |