K123700 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 11, 2013, 129 days after receiving the submission on December 3, 2012.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K123700 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 03, 2012 |
| Decision Date | April 11, 2013 |
| Days to Decision | 129 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 |