The following data is part of a premarket notification filed by Spectros Corporation with the FDA for T-stat Microvascular Tissue Oximeter, Model 303.
| Device ID | K040684 |
| 510k Number | K040684 |
| Device Name: | T-STAT MICROVASCULAR TISSUE OXIMETER, MODEL 303 |
| Classification | Oximeter, Tissue Saturation |
| Applicant | SPECTROS CORPORATION 4370 ALPINE ROAD SUITE 108 Portola Valley, CA 94028 |
| Contact | David A Benaron |
| Correspondent | David A Benaron SPECTROS CORPORATION 4370 ALPINE ROAD SUITE 108 Portola Valley, CA 94028 |
| Product Code | MUD |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-16 |
| Decision Date | 2004-11-05 |
| Summary: | summary |