K190270 is an FDA 510(k) clearance for the FORE-SIGHT ELITE Tissue Oximeter Module. This device is classified as a Oximeter, Tissue Saturation (Class II - Special Controls, product code MUD).
Submitted by Cas Medical Systems, Inc. (Branford, US). The FDA issued a Cleared decision on October 21, 2019, 255 days after receiving the submission on February 8, 2019.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K190270 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 08, 2019 |
| Decision Date | October 21, 2019 |
| Days to Decision | 255 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 |