FDA 510(k)

Kowa SL-19

Número K: K222372 · 2022-11-21

Data da decisão2022-11-21

Código do produtoHJO

Comité consultivoOP

DecisãoSubstantially Equivalent

Resumo do dispositivo

Kowa SL-19 is the device name listed in this FDA 510(k) record. The listed applicant is Kowa Company , Ltd.. It received FDA 510(k) clearance on 2022-11-21 under 510(k) number K222372. The device is classified under product code HJO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Kowa SL-19?

Kowa SL-19 is a medical device that received FDA 510(k) clearance on 2022-11-21. The listed applicant is Kowa Company , Ltd.. The 510(k) number is K222372.

When did Kowa SL-19 receive FDA 510(k) clearance?

Kowa SL-19 received FDA 510(k) clearance on 2022-11-21, under 510(k) number K222372.

Who is the listed applicant for Kowa SL-19?

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

What is the FDA product code for Kowa SL-19?

The FDA product code for Kowa SL-19 is HJO.

Outros registros que listam Kowa Company , Ltd. 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.

K191945KOWA nonmyd 8 K190573KOWA DR-1a

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Fonte oficial

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