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 sensor, single-use FDA UDI
Device Name: 2.5 cm diameter surface probe for use with the T-Stat Monitor to measure ischemia. FDA UDI
Model / Reference: CTH-060-SUR 2.5cm FDA UDI
Description: 2.5 cm diameter surface probe for use with the T-Stat Monitor to measure ischemia. FDA UDI

Identifiers

Primary DI / UDI-DI: 00851136007001 FDA UDI
510(k) Number: K081233 FDA UDI
FDA Product Code: MUD FDA UDI
GMDN Term: Tissue saturation oximeter sensor, single-use 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

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Tissue saturation oximeter sensor, single-use

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 b4e14bd0-60d0-4408-b830-6dd41e0ab0ec 35 fields · synced May 30, 2026