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FDA 510(k)

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

K-Number: K233354 · 2024-06-26

ApplicantAthena Gtx, Inc.
Decision Date2024-06-26
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

WVSM Pro (Series) (500-0030-XX) is a medical device manufactured by Athena Gtx, Inc.. It received FDA 510(k) clearance on 2024-06-26 under approval number K233354. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Athena Gtx, Inc.. The 510(k) number is K233354.

When was WVSM Pro (Series) (500-0030-XX) approved by the FDA?

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

What company makes WVSM Pro (Series) (500-0030-XX)?

WVSM Pro (Series) (500-0030-XX) is manufactured by Athena Gtx, Inc..

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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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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