FDA 510(k)

LOGIQ E10s, LOGIQ Fortis

Número K: K211524 · 2021-08-27

Data da decisão2021-08-27

Código do produtoIYN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

LOGIQ E10s, LOGIQ Fortis is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare. It received FDA 510(k) clearance on 2021-08-27 under 510(k) number K211524. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the LOGIQ E10s, LOGIQ Fortis?

LOGIQ E10s, LOGIQ Fortis is a medical device that received FDA 510(k) clearance on 2021-08-27. The listed applicant is GE Healthcare. The 510(k) number is K211524.

When did LOGIQ E10s, LOGIQ Fortis receive FDA 510(k) clearance?

LOGIQ E10s, LOGIQ Fortis received FDA 510(k) clearance on 2021-08-27, under 510(k) number K211524.

Who is the listed applicant for LOGIQ E10s, LOGIQ Fortis?

The FDA 510(k) record lists GE Healthcare as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LOGIQ E10s, LOGIQ Fortis?

The FDA product code for LOGIQ E10s, LOGIQ Fortis is IYN.

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Fonte oficial

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