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Integrity, Model V500

by Vivosonic Inc

510(k) K043396

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK043396 Date24 Jan 2005ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
GWJ
FDA applicant
Vivosonic, Inc.
Device class
Class II
Regulation
21 CFR Part 882.1900
Advisory committee
Neurology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Integrity, Model V500 is an auditory evoked response stimulator device. It is designed to generate auditory stimuli for neurological testing purposes. The device is classified under product code GWJ and is intended for use in neurology applications.

The Integrity, Model V500 is manufactured by Vivosonic Inc and received FDA 510(k) clearance with number K043396 on January 24, 2005. It is a Class II device that was reviewed by the Neurology advisory committee. The device is supplied with various model numbers and registration numbers as specified in the device data.

Devices cleared under K043396

28 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K043396
UDI-DISize and differences
Bone Conductor B81
Vivosonic Inc
B8100627908020192
Single use: no
On the market
EarDome 100004
Vivosonic Inc
10000400627908070074
Single use: yes
On the market
ECochG Adapters E-110
Vivosonic Inc
E-11000627908020185
Single use: no
On the market
EP Headphones H-802
Vivosonic Inc
H-80200627908020178
Single use: no
On the market
Integrity Amplitrode A61
Vivosonic Inc
A6100627908010025
Single use: no
On the market
Integrity Amplitrode A81
Vivosonic Inc
A8100627908020024
Single use: no
On the market
Integrity Amplitrode A82
Vivosonic Inc
A8200627908020031
Single use: no
On the market
Integrity Bone Conductor B71-10
Vivosonic Inc
B71-1000627908010032
Single use: no
On the market
Integrity Bone Conductor B71W
Vivosonic Inc
B71W00627908020055
Single use: no
On the market
Integrity Computer M500-C
Vivosonic Inc
M500-C00627908020130
Single use: no
On the market
Integrity CV-Amp A91
Vivosonic Inc
A9100627908020147
Single use: no
On the market
Integrity EP Headphones H-800
Vivosonic Inc
H-80000627908020093
Single use: no
On the market
Integrity EP Headphones H-801
Vivosonic Inc
H-80100627908020109
Single use: no
On the market
Integrity EP Headphones HDA 300
Vivosonic Inc
HDA 30000627908010056
Single use: no
On the market
Integrity Insert Earphones ER-2-800
Vivosonic Inc
ER-2-80000627908020062
Single use: no
On the market
Integrity Insert Earphones ER-3A-800
Vivosonic Inc
ER-3A-80000627908020079
Single use: no
On the market
Integrity Insert Earphones ER-3A-ABR
Vivosonic Inc
ER-3A-ABR00627908010049
Single use: no
On the market
Integrity Insert Earphones ER-3C-800
Vivosonic Inc
ER-3C-80000627908020086
Single use: no
On the market
Integrity OAE Probe P40-GP
Vivosonic Inc
P40-GP00627908010063
Single use: no
On the market
Integrity OAE Probe P40-UG
Vivosonic Inc
P40-UG00627908010070
Single use: no
On the market
Integrity OAE Probe P81-GP
Vivosonic Inc
P81-GP00627908020116
Single use: no
On the market
Integrity OAE Probe P81-UG
Vivosonic Inc
P81-UG00627908020123
Single use: no
On the market
Integrity Software SWA001
Vivosonic Inc
SWA00100627908090010
Single use: no
On the market
Integrity V500
Vivosonic Inc
V50000627908010018
Single use: no
On the market
Integrity V500
Vivosonic Inc
V50000627908020017
Single use: no
On the market
Integrity VivoAmp A90
Vivosonic Inc
A9000627908020048
Single use: no
On the market
Integrity VivoStim ST-800
Vivosonic Inc
ST-80000627908020154
Single use: no
On the market
VivoTab Electrode (4 pack) 100001
Vivosonic Inc
10000100627908070067
Single use: yes
On the market

Similar devices

Other devices filed under FDA product code GWJ (Stimulator, Auditory, Evoked Response).

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