FDA 510(k)

Myo Plus

Número K: K191179 · 2019-09-04

RequerenteOtto Bock Healthcare Products GmbH

Data da decisão2019-09-04

Código do produtoGXY

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Myo Plus is the device name listed in this FDA 510(k) record. The listed applicant is Otto Bock Healthcare Products GmbH. It received FDA 510(k) clearance on 2019-09-04 under 510(k) number K191179. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Myo Plus?

Myo Plus is a medical device that received FDA 510(k) clearance on 2019-09-04. The listed applicant is Otto Bock Healthcare Products GmbH. The 510(k) number is K191179.

When did Myo Plus receive FDA 510(k) clearance?

Myo Plus received FDA 510(k) clearance on 2019-09-04, under 510(k) number K191179.

Who is the listed applicant for Myo Plus?

The FDA 510(k) record lists Otto Bock Healthcare Products GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Myo Plus?

The FDA product code for Myo Plus is GXY.

Outros registros que listam Otto Bock Healthcare Products 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.

K253256myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T)

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Fonte oficial

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