FDA 510(k)

WVSM Pro (Series) (500-0030-XX)

Número K: K233354 · 2024-06-26

Data da decisão2024-06-26

Código do produtoMWI

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

WVSM Pro (Series) (500-0030-XX) is the device name listed in this FDA 510(k) record. The listed applicant is Athena Gtx, Inc.. It received FDA 510(k) clearance on 2024-06-26 under 510(k) number K233354. 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 WVSM Pro (Series) (500-0030-XX)?

WVSM Pro (Series) (500-0030-XX) is a medical device that received FDA 510(k) clearance on 2024-06-26. The listed applicant is Athena Gtx, Inc.. The 510(k) number is K233354.

When did WVSM Pro (Series) (500-0030-XX) receive FDA 510(k) clearance?

WVSM Pro (Series) (500-0030-XX) received FDA 510(k) clearance on 2024-06-26, under 510(k) number K233354.

Who is the listed applicant for WVSM Pro (Series) (500-0030-XX)?

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

What is the FDA product code for WVSM Pro (Series) (500-0030-XX)?

The FDA product code for WVSM Pro (Series) (500-0030-XX) is MWI.

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Fonte oficial

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