FDA 510(k)

Huma RPM (RPM)

Número K: K230214 · 2023-06-02

Data da decisão2023-06-02

Código do produtoMWI

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Huma RPM (RPM) is the device name listed in this FDA 510(k) record. The listed applicant is Medopad, Inc.. It received FDA 510(k) clearance on 2023-06-02 under 510(k) number K230214. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Huma RPM (RPM)?

Huma RPM (RPM) is a medical device that received FDA 510(k) clearance on 2023-06-02. The listed applicant is Medopad, Inc.. The 510(k) number is K230214.

When did Huma RPM (RPM) receive FDA 510(k) clearance?

Huma RPM (RPM) received FDA 510(k) clearance on 2023-06-02, under 510(k) number K230214.

Who is the listed applicant for Huma RPM (RPM)?

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

What is the FDA product code for Huma RPM (RPM)?

The FDA product code for Huma RPM (RPM) is MWI.

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Fonte oficial

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