FDA 510(k)

LOGIQ S7 Expert

Número K: K160182 · 2016-02-26

Data da decisão2016-02-26

Código do produtoIYN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

LOGIQ S7 Expert is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare. It received FDA 510(k) clearance on 2016-02-26 under 510(k) number K160182. 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 S7 Expert?

LOGIQ S7 Expert is a medical device that received FDA 510(k) clearance on 2016-02-26. The listed applicant is GE Healthcare. The 510(k) number is K160182.

When did LOGIQ S7 Expert receive FDA 510(k) clearance?

LOGIQ S7 Expert received FDA 510(k) clearance on 2016-02-26, under 510(k) number K160182.

Who is the listed applicant for LOGIQ S7 Expert?

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 S7 Expert?

The FDA product code for LOGIQ S7 Expert is IYN.

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Fonte oficial

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