K081233 is an FDA 510(k) clearance for the T-STAT 303 ISCHEMIA MONITORING SYSTEM. This device is classified as a Oximeter, Tissue Saturation (Class II - Special Controls, product code MUD).
Submitted by Spectros Corporation (Highlands Ranch, US). The FDA issued a Cleared decision on July 28, 2008, 88 days after receiving the submission on May 1, 2008.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K081233 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 01, 2008 |
| Decision Date | July 28, 2008 |
| Days to Decision | 88 days |
| Submission Type | Special |
| 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 |