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FDA 510(k)

Integrity V500 (Integrity, Integrity with VEMP)

K-Number: K242954 · 2024-12-19

ApplicantVivosonic, Inc.
Decision Date2024-12-19
Product CodeGWJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Integrity V500 (Integrity, Integrity with VEMP) is the device name listed in this FDA 510(k) record. The listed applicant is Vivosonic, Inc.. It received FDA 510(k) clearance on 2024-12-19 under 510(k) number K242954. The device is classified under product code GWJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Integrity V500 (Integrity, Integrity with VEMP)?

Integrity V500 (Integrity, Integrity with VEMP) is a medical device that received FDA 510(k) clearance on 2024-12-19. The listed applicant is Vivosonic, Inc.. The 510(k) number is K242954.

When did Integrity V500 (Integrity, Integrity with VEMP) receive FDA 510(k) clearance?

Integrity V500 (Integrity, Integrity with VEMP) received FDA 510(k) clearance on 2024-12-19, under 510(k) number K242954.

Who is the listed applicant for Integrity V500 (Integrity, Integrity with VEMP)?

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

What is the FDA product code for Integrity V500 (Integrity, Integrity with VEMP)?

The FDA product code for Integrity V500 (Integrity, Integrity with VEMP) is GWJ.

Related Devices (Code: GWJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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