FDA 510(k)

Cumulus Remover

Número K: K182002 · 2018-10-23

Data da decisão2018-10-23

Código do produtoMQL

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

Cumulus Remover is the device name listed in this FDA 510(k) record. The listed applicant is Kitazato Corporation. It received FDA 510(k) clearance on 2018-10-23 under 510(k) number K182002. 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 Cumulus Remover?

Cumulus Remover is a medical device that received FDA 510(k) clearance on 2018-10-23. The listed applicant is Kitazato Corporation. The 510(k) number is K182002.

When did Cumulus Remover receive FDA 510(k) clearance?

Cumulus Remover received FDA 510(k) clearance on 2018-10-23, under 510(k) number K182002.

Who is the listed applicant for Cumulus Remover?

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 Cumulus Remover?

The FDA product code for Cumulus Remover is MQL.

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Fonte oficial

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