FDA 510(k)

Visalis V500, Visalis S500

Número K: K193376 · 2020-06-15

Data da decisão2020-06-15

Código do produtoHQC

Comité consultivoOP

DecisãoSubstantially Equivalent

Resumo do dispositivo

Visalis V500, Visalis S500 is the device name listed in this FDA 510(k) record. The listed applicant is Carl Zeiss Meditec, AG. It received FDA 510(k) clearance on 2020-06-15 under 510(k) number K193376. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Visalis V500, Visalis S500?

Visalis V500, Visalis S500 is a medical device that received FDA 510(k) clearance on 2020-06-15. The listed applicant is Carl Zeiss Meditec, AG. The 510(k) number is K193376.

When did Visalis V500, Visalis S500 receive FDA 510(k) clearance?

Visalis V500, Visalis S500 received FDA 510(k) clearance on 2020-06-15, under 510(k) number K193376.

Who is the listed applicant for Visalis V500, Visalis S500?

The FDA 510(k) record lists Carl Zeiss Meditec, AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Visalis V500, Visalis S500?

The FDA product code for Visalis V500, Visalis S500 is HQC.

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Fonte oficial

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