Cleared Traditional

Integrity V500 (Integrity, Integrity with VEMP)

K242954 · Vivosonic, Inc. · Ear, Nose, Throat

Dec 2024

Decision

85d

Days

Class 2

Risk

About This 510(k) Submission

K242954 is an FDA 510(k) clearance for the Integrity V500 (Integrity, Integrity with VEMP), a Stimulator, Auditory, Evoked Response (Class II — Special Controls, product code GWJ), submitted by Vivosonic, Inc. (Toronto, CA). The FDA issued a Cleared decision on December 19, 2024, 85 days after receiving the submission on September 25, 2024. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 882.1900.

Submission Details

510(k) Number	K242954 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 25, 2024
Decision Date	December 19, 2024
Days to Decision	85 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF