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FDA 510(k)

T-Stat 2.0 Microvascular Tissue Oximeter

K-Number: K192322 · 2019-09-23

ApplicantSpectros Corporation
Decision Date2019-09-23
Product CodeMUD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

T-Stat 2.0 Microvascular Tissue Oximeter is a medical device manufactured by Spectros Corporation. It received FDA 510(k) clearance on 2019-09-23 under approval number K192322. The device is classified under product code MUD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the T-Stat 2.0 Microvascular Tissue Oximeter?

T-Stat 2.0 Microvascular Tissue Oximeter is a medical device that received FDA 510(k) clearance on 2019-09-23. It is manufactured by Spectros Corporation. The 510(k) number is K192322.

When was T-Stat 2.0 Microvascular Tissue Oximeter approved by the FDA?

T-Stat 2.0 Microvascular Tissue Oximeter received FDA 510(k) clearance on 2019-09-23, under approval number K192322.

What company makes T-Stat 2.0 Microvascular Tissue Oximeter?

T-Stat 2.0 Microvascular Tissue Oximeter is manufactured by Spectros Corporation.

What is the FDA product code for T-Stat 2.0 Microvascular Tissue Oximeter?

The FDA product code for T-Stat 2.0 Microvascular Tissue Oximeter is MUD.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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