FDA 510(k)

iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA

Número K: K193522 · 2020-08-25

Data da decisão2020-08-25

Código do produtoMQL

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA is the device name listed in this FDA 510(k) record. The listed applicant is Kitazato Corporation. It received FDA 510(k) clearance on 2020-08-25 under 510(k) number K193522. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA?

iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA is a medical device that received FDA 510(k) clearance on 2020-08-25. The listed applicant is Kitazato Corporation. The 510(k) number is K193522.

When did iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA receive FDA 510(k) clearance?

iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA received FDA 510(k) clearance on 2020-08-25, under 510(k) number K193522.

Who is the listed applicant for iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA?

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

What is the FDA product code for iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA?

The FDA product code for iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA is MQL.

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Outros registros que listam Kitazato Corporation como candidato(a)

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Dispositivos Relacionados (Código: MQL)

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Fonte oficial

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