The T-Stat 303 Microvascular Tissue Oximeter provides a continuous, non-invasive, and localized measurement of the microvascular hemoglobin oxygen saturation, sensitive to regional and…
The T-Stat 303 Microvascular Tissue Oximeter provides a continuous, non-invasive, and localized measurement of the microvascular hemoglobin oxygen saturation, sensitive to regional and global reduced flow or no-flow ischemia. It is intended for use as an adjunct monitor of the localized hemoglobin oxygen saturation of blood in microvascular tissue spaces.
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (2), Sichuan (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for Spectros T-Stat | Listed by | Spectros Corporation, United States |
| FDA product code | MUD |
| Device type | Oximeter, Tissue Saturation |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2700 |
| 510(k) | K081233 |
| Record published | 2016-10-17 |
| Record revised | 2018-07-06 (version 4) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Box of 5 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.