FDA 510(k)

Image1 SPIES System

Número K: K160044 · 2016-02-01

RequerenteKarl Storz Endoscopy America, Inc.

Data da decisão2016-02-01

Código do produtoFET

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Image1 SPIES System is the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz Endoscopy America, Inc.. It received FDA 510(k) clearance on 2016-02-01 under 510(k) number K160044. The device is classified under product code FET. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Image1 SPIES System?

Image1 SPIES System is a medical device that received FDA 510(k) clearance on 2016-02-01. The listed applicant is Karl Storz Endoscopy America, Inc.. The 510(k) number is K160044.

When did Image1 SPIES System receive FDA 510(k) clearance?

Image1 SPIES System received FDA 510(k) clearance on 2016-02-01, under 510(k) number K160044.

Who is the listed applicant for Image1 SPIES System?

The FDA 510(k) record lists Karl Storz Endoscopy America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Image1 SPIES System?

The FDA product code for Image1 SPIES System is FET.

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Fonte oficial

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