FDA 510(k)

T-Stat 2.0 Microvascular Tissue Oximeter

Número K: K192322 · 2019-09-23

Data da decisão2019-09-23

Código do produtoMUD

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

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

Perguntas frequentes

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. The listed applicant is Spectros Corporation. The 510(k) number is K192322.

When did T-Stat 2.0 Microvascular Tissue Oximeter receive FDA 510(k) clearance?

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

Who is the listed applicant for T-Stat 2.0 Microvascular Tissue Oximeter?

The FDA 510(k) record lists Spectros Corporation as the applicant. This does not by itself establish the device manufacturer.

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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