FDA 510(k)

truFreeze System

Número K: K160273 · 2016-03-25

Data da decisão2016-03-25

Código do produtoGEH

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

truFreeze System is the device name listed in this FDA 510(k) record. The listed applicant is Csa Medial, Inc.. It received FDA 510(k) clearance on 2016-03-25 under 510(k) number K160273. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the truFreeze System?

truFreeze System is a medical device that received FDA 510(k) clearance on 2016-03-25. The listed applicant is Csa Medial, Inc.. The 510(k) number is K160273.

When did truFreeze System receive FDA 510(k) clearance?

truFreeze System received FDA 510(k) clearance on 2016-03-25, under 510(k) number K160273.

Who is the listed applicant for truFreeze System?

The FDA 510(k) record lists Csa Medial, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for truFreeze System?

The FDA product code for truFreeze System is GEH.

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