Spectros T-Stat

FDA UDI

Class II (US FDA UDI)

by Spectros Corporation

Identity

Trade Name: Spectros T-Stat FDA UDI
Generic Name: Tissue saturation oximeter FDA UDI
Device Name: 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. FDA UDI
Model / Reference: T-Stat 303 FDA UDI
Description: 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. FDA UDI

Identifiers

Catalog Number: T-Stat 303 FDA UDI
Primary DI / UDI-DI: 00851136007056 FDA UDI
510(k) Number: K081233 FDA UDI
FDA Product Code: MUD FDA UDI
GMDN Term: Tissue saturation oximeter FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.2700 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Tissue saturation oximeter

Spectros T-Stat by Spectros Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K081233 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Spectros Corporation

Sources (1)

FDA UDI 66164231-8f8b-4be1-af54-95e3ba1d0de9 36 fields · synced May 30, 2026