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FDA 510(k)

SMARTVERTIGO™ Vestibular Assessment System

K-Number: K260566 · 2026-07-30

ApplicantVertigoDx, Inc.
Decision Date2026-07-30
Product CodeGWN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SMARTVERTIGO™ Vestibular Assessment System is the device name listed in this FDA 510(k) record. The listed applicant is VertigoDx, Inc.. It received FDA 510(k) clearance on 2026-07-30 under 510(k) number K260566. The device is classified under product code GWN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMARTVERTIGO™ Vestibular Assessment System?

SMARTVERTIGO™ Vestibular Assessment System is a medical device that received FDA 510(k) clearance on 2026-07-30. The listed applicant is VertigoDx, Inc.. The 510(k) number is K260566.

When did SMARTVERTIGO™ Vestibular Assessment System receive FDA 510(k) clearance?

SMARTVERTIGO™ Vestibular Assessment System received FDA 510(k) clearance on 2026-07-30, under 510(k) number K260566.

Who is the listed applicant for SMARTVERTIGO™ Vestibular Assessment System?

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

What is the FDA product code for SMARTVERTIGO™ Vestibular Assessment System?

The FDA product code for SMARTVERTIGO™ Vestibular Assessment System is GWN.

Related Devices (Code: GWN)

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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