The following data is part of a premarket notification filed by Edwards Lifesciences, Llc with the FDA for Fore-sight Elite Absolute Tissue Oximeter.
| Device ID | K203490 |
| 510k Number | K203490 |
| Device Name: | FORE-SIGHT ELITE Absolute Tissue Oximeter |
| Classification | Oximeter, Tissue Saturation |
| Applicant | Edwards Lifesciences, LLC One Edwards Way Irvine, CA 92614 |
| Contact | Michelle Ducca |
| Correspondent | Michelle Ducca Edwards Lifesciences, LLC One Edwards Way Irvine, CA 92614 |
| Product Code | MUD |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-27 |
| Decision Date | 2021-02-10 |