FDA 510(k)

VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack

Número K: K172748 · 2018-02-09

Data da decisão2018-02-09

Código do produtoFRC

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack is the device name listed in this FDA 510(k) record. The listed applicant is Steris Corporations. It received FDA 510(k) clearance on 2018-02-09 under 510(k) number K172748. The device is classified under product code FRC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack?

VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack is a medical device that received FDA 510(k) clearance on 2018-02-09. The listed applicant is Steris Corporations. The 510(k) number is K172748.

When did VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack receive FDA 510(k) clearance?

VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack received FDA 510(k) clearance on 2018-02-09, under 510(k) number K172748.

Who is the listed applicant for VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack?

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

What is the FDA product code for VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack?

The FDA product code for VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack is FRC.

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Fonte oficial

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