Duns Number:929856680
Device Description: The T-Stat 303 Microvascular Tissue Oximeter provides a continuous, non-invasive, and loca 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.
Catalog Number
T-Stat 303
Brand Name
Spectros T-Stat
Version/Model Number
T-Stat 303
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K081233
Product Code
MUD
Product Code Name
Oximeter, Tissue Saturation
Public Device Record Key
66164231-8f8b-4be1-af54-95e3ba1d0de9
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 03, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |