FDA 510(k)

KOWA DR-1a

Número K: K190573 · 2019-06-04

Data da decisão2019-06-04

Código do produtoHKI

Comité consultivoOP

DecisãoSubstantially Equivalent

Resumo do dispositivo

KOWA DR-1a 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 2019-06-04 under 510(k) number K190573. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the KOWA DR-1a?

KOWA DR-1a is a medical device that received FDA 510(k) clearance on 2019-06-04. The listed applicant is Kowa Company , Ltd.. The 510(k) number is K190573.

When did KOWA DR-1a receive FDA 510(k) clearance?

KOWA DR-1a received FDA 510(k) clearance on 2019-06-04, under 510(k) number K190573.

Who is the listed applicant for KOWA DR-1a?

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 DR-1a?

The FDA product code for KOWA DR-1a is HKI.

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.

K222372Kowa SL-19 K191945KOWA nonmyd 8

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Fonte oficial

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