FDA 510(k)

myQA iON

Número K: K201798 · 2020-07-17

Data da decisão2020-07-17

Código do produtoLHN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

myQA iON is the device name listed in this FDA 510(k) record. The listed applicant is Iba Dosimetry GmbH. It received FDA 510(k) clearance on 2020-07-17 under 510(k) number K201798. The device is classified under product code LHN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the myQA iON?

myQA iON is a medical device that received FDA 510(k) clearance on 2020-07-17. The listed applicant is Iba Dosimetry GmbH. The 510(k) number is K201798.

When did myQA iON receive FDA 510(k) clearance?

myQA iON received FDA 510(k) clearance on 2020-07-17, under 510(k) number K201798.

Who is the listed applicant for myQA iON?

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

What is the FDA product code for myQA iON?

The FDA product code for myQA iON is LHN.

Outros registros que listam Iba Dosimetry GmbH como candidato(a)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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Fonte oficial

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