FDA 510(k)

Peak.me

Número K: K180487 · 2018-10-26

Data da decisão2018-10-26

Código do produtoBZH

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Peak.me is the device name listed in this FDA 510(k) record. The listed applicant is Breathe Me, Ltd.. It received FDA 510(k) clearance on 2018-10-26 under 510(k) number K180487. The device is classified under product code BZH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Peak.me?

Peak.me is a medical device that received FDA 510(k) clearance on 2018-10-26. The listed applicant is Breathe Me, Ltd.. The 510(k) number is K180487.

When did Peak.me receive FDA 510(k) clearance?

Peak.me received FDA 510(k) clearance on 2018-10-26, under 510(k) number K180487.

Who is the listed applicant for Peak.me?

The FDA 510(k) record lists Breathe Me, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Peak.me?

The FDA product code for Peak.me is BZH.

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Fonte oficial

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