FDA 510(k)

CMOS Video Esophagoscope SSU

Número K: K192523 · 2020-01-24

Data da decisão2020-01-24

Código do produtoEOX

Comité consultivoEN

DecisãoSubstantially Equivalent

Resumo do dispositivo

CMOS Video Esophagoscope SSU is the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz SE & CO. KG. It received FDA 510(k) clearance on 2020-01-24 under 510(k) number K192523. The device is classified under product code EOX. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CMOS Video Esophagoscope SSU?

CMOS Video Esophagoscope SSU is a medical device that received FDA 510(k) clearance on 2020-01-24. The listed applicant is Karl Storz SE & CO. KG. The 510(k) number is K192523.

When did CMOS Video Esophagoscope SSU receive FDA 510(k) clearance?

CMOS Video Esophagoscope SSU received FDA 510(k) clearance on 2020-01-24, under 510(k) number K192523.

Who is the listed applicant for CMOS Video Esophagoscope SSU?

The FDA 510(k) record lists Karl Storz SE & CO. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CMOS Video Esophagoscope SSU?

The FDA product code for CMOS Video Esophagoscope SSU is EOX.

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Fonte oficial

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