The following data is part of a premarket notification filed by Spectros Corporation with the FDA for T-stat 2.0 Microvascular Tissue Oximeter.
| Device ID | K192322 |
| 510k Number | K192322 |
| Device Name: | T-Stat 2.0 Microvascular Tissue Oximeter |
| Classification | Oximeter, Tissue Saturation |
| Applicant | Spectros Corporation 274 E Hamilton Ave Suite H Campbell, CA 95008 |
| Contact | Bill Curnan |
| Correspondent | Bill Curnan Spectros Corporation 274 E Hamilton Ave Suite H Campbell, CA 95008 |
| Product Code | MUD |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-27 |
| Decision Date | 2019-09-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851136007063 | K192322 | 000 |