510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K043396Substantially Equivalent

Integrity, Model V500

Vivosonic Inc., Toronto, On, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K043396 is the FDA 510(k) clearance record for INTEGRITY, MODEL V500, a class II device, cleared for Vivosonic, Inc. on under FDA product code GWJ (Stimulator, Auditory, Evoked Response). FDA records list 5 510(k) clearances for Vivosonic, Inc., from to . As of , FDA records show no recalls naming K043396.

Clearance record

Decision date
Received
(45 days to decision)
Product code
GWJ Stimulator, Auditory, Evoked Response
Regulation
21 CFR 882.1900
Device class
Class II
Review panel
Neurology
Applicant
Vivosonic, Inc. 56 Aberfoyle Crescent, Toronto, On, CA
510(k) summary
Statement
Third party review
Yes

Clearances, product code GWJ

Trailing 12 months

FDA records hold no clearances under product code GWJ in the trailing twelve months.

FDA records show no clearances under product code GWJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GWJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260