FDA 510(k)

SteriZign Signatur Device Protection System

Número K: K171520 · 2018-02-07

RequerenteSterizign Precision Technologies, LLC

Data da decisão2018-02-07

Código do produtoKCT

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

SteriZign Signatur Device Protection System is the device name listed in this FDA 510(k) record. The listed applicant is Sterizign Precision Technologies, LLC. It received FDA 510(k) clearance on 2018-02-07 under 510(k) number K171520. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SteriZign Signatur Device Protection System?

SteriZign Signatur Device Protection System is a medical device that received FDA 510(k) clearance on 2018-02-07. The listed applicant is Sterizign Precision Technologies, LLC. The 510(k) number is K171520.

When did SteriZign Signatur Device Protection System receive FDA 510(k) clearance?

SteriZign Signatur Device Protection System received FDA 510(k) clearance on 2018-02-07, under 510(k) number K171520.

Who is the listed applicant for SteriZign Signatur Device Protection System?

The FDA 510(k) record lists Sterizign Precision Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SteriZign Signatur Device Protection System?

The FDA product code for SteriZign Signatur Device Protection System is KCT.

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