FDA 510(k)

D²RS and D²RS 9090

Número K: K213479 · 2021-12-23

Data da decisão2021-12-23

Código do produtoOWB

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

D²RS and D²RS 9090 is the device name listed in this FDA 510(k) record. The listed applicant is Stephanix. It received FDA 510(k) clearance on 2021-12-23 under 510(k) number K213479. 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 D²RS and D²RS 9090?

D²RS and D²RS 9090 is a medical device that received FDA 510(k) clearance on 2021-12-23. The listed applicant is Stephanix. The 510(k) number is K213479.

When did D²RS and D²RS 9090 receive FDA 510(k) clearance?

D²RS and D²RS 9090 received FDA 510(k) clearance on 2021-12-23, under 510(k) number K213479.

Who is the listed applicant for D²RS and D²RS 9090?

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

What is the FDA product code for D²RS and D²RS 9090?

The FDA product code for D²RS and D²RS 9090 is OWB.

Outros registros que listam Stephanix 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.

K221335D²RS and D²RS 9090 K212515MOVIX DReamy

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Fonte oficial

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