FDA 510(k)

C015

Número K: K192182 · 2020-01-17

Data da decisão2020-01-17

Código do produtoOWB

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

C015 is the device name listed in this FDA 510(k) record. The listed applicant is Micronica Srl. It received FDA 510(k) clearance on 2020-01-17 under 510(k) number K192182. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the C015?

C015 is a medical device that received FDA 510(k) clearance on 2020-01-17. The listed applicant is Micronica Srl. The 510(k) number is K192182.

When did C015 receive FDA 510(k) clearance?

C015 received FDA 510(k) clearance on 2020-01-17, under 510(k) number K192182.

Who is the listed applicant for C015?

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

What is the FDA product code for C015?

The FDA product code for C015 is OWB.

Dispositivos Relacionados (Código: OWB)

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Fonte oficial

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