FDA 510(k)

Bongo

Número K: K180619 · 2018-08-16

Data da decisão2018-08-16

Código do produtoOHP

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Bongo is the device name listed in this FDA 510(k) record. The listed applicant is Innomed Healthscience, Inc.. It received FDA 510(k) clearance on 2018-08-16 under 510(k) number K180619. The device is classified under product code OHP. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Bongo?

Bongo is a medical device that received FDA 510(k) clearance on 2018-08-16. The listed applicant is Innomed Healthscience, Inc.. The 510(k) number is K180619.

When did Bongo receive FDA 510(k) clearance?

Bongo received FDA 510(k) clearance on 2018-08-16, under 510(k) number K180619.

Who is the listed applicant for Bongo?

The FDA 510(k) record lists Innomed Healthscience, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bongo?

The FDA product code for Bongo is OHP.

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