FDA 510(k)

QUATERA 700

Número K: K212241 · 2022-04-19

Data da decisão2022-04-19

Código do produtoHQC

Comité consultivoOP

DecisãoSubstantially Equivalent

Resumo do dispositivo

QUATERA 700 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 2022-04-19 under 510(k) number K212241. 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 QUATERA 700?

QUATERA 700 is a medical device that received FDA 510(k) clearance on 2022-04-19. The listed applicant is Carl Zeiss Meditec, AG. The 510(k) number is K212241.

When did QUATERA 700 receive FDA 510(k) clearance?

QUATERA 700 received FDA 510(k) clearance on 2022-04-19, under 510(k) number K212241.

Who is the listed applicant for QUATERA 700?

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 QUATERA 700?

The FDA product code for QUATERA 700 is HQC.

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Fonte oficial

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