K040684 is an FDA 510(k) clearance for the T-STAT MICROVASCULAR TISSUE OXIMETER, MODEL 303. This device is classified as a Oximeter, Tissue Saturation (Class II - Special Controls, product code MUD).
Submitted by Spectros Corporation (Portola Valley, US). The FDA issued a Cleared decision on November 5, 2004, 234 days after receiving the submission on March 16, 2004.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K040684 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 16, 2004 |
| Decision Date | November 05, 2004 |
| Days to Decision | 234 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 |