K143675 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 Cas Medical Systems, Inc. (Branford, US). The FDA issued a Cleared decision on April 10, 2015, 107 days after receiving the submission on December 24, 2014.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K143675 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 24, 2014 |
| Decision Date | April 10, 2015 |
| Days to Decision | 107 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 |