The following data is part of a premarket notification filed by Spectros Corporation with the FDA for T-stat 303 Ischemia Monitoring System.
| Device ID | K081233 |
| 510k Number | K081233 |
| Device Name: | T-STAT 303 ISCHEMIA MONITORING SYSTEM |
| Classification | Oximeter, Tissue Saturation |
| Applicant | SPECTROS CORPORATION 9433 SOUTH MORNING GLORY LANE Highlands Ranch, CO 80130 |
| Contact | Bill Curnan |
| Correspondent | Bill Curnan SPECTROS CORPORATION 9433 SOUTH MORNING GLORY LANE Highlands Ranch, CO 80130 |
| Product Code | MUD |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-01 |
| Decision Date | 2008-07-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851136007056 | K081233 | 000 |
| 10851136007046 | K081233 | 000 |
| 10851136007039 | K081233 | 000 |
| 00851136007025 | K081233 | 000 |
| 10851136007015 | K081233 | 000 |
| 10851136007008 | K081233 | 000 |