K230612 is an FDA 510(k) clearance for the Edwards Algorithm for Measurement of Blood Hemoglobin. 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 November 17, 2023, 256 days after receiving the submission on March 6, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K230612 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 06, 2023 |
| Decision Date | November 17, 2023 |
| Days to Decision | 256 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MUD — Oximeter, Tissue Saturation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2700 |