K203490 is an FDA 510(k) clearance for the FORE-SIGHT ELITE Absolute Tissue Oximeter. 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 February 10, 2021, 75 days after receiving the submission on November 27, 2020.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K203490 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 27, 2020 |
| Decision Date | February 10, 2021 |
| Days to Decision | 75 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | MUD — Oximeter, Tissue Saturation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2700 |