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510(k) K242954

Device
Integrity V500 (Integrity, Integrity with VEMP)
Applicant
Vivosonic, Inc.
510(k) number
K242954
Product code
GWJ
Decision
Substantially Equivalent (SESE)
Decision date
2024-12-19
Date received
2024-09-25
Regulation
882.1900
Classification name
Stimulator, Auditory, Evoked Response
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Trevor Rocheleau
Address
222-5535 Eglinton Ave. W. Toronto CA M9C 5K5 M9C 5K5

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GWJ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K233649ALGO Pro Newborn Hearing Screener (ALGO Pro)Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)2024-03-08
K220139QScreenPath Medical GmbH2022-08-03
K211147ALGO 7iPath Medical GmbH2021-10-14
K193033GSI Audera ProGrason Stadler2020-04-24
K163326SmartEPIntelligent Hearing Systems2017-09-29
K162037Eclipse with VEMPInteracoustics A/S2017-03-23
K143670ICS CHARTR EP 200 WITH VEMPGn Otometrics A/S2015-10-23
K141446ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO HEARING SCREENER WITHOUT BARCODE SCANNER,Natus Medical Incorporated2014-08-22
K132957MADSEN ACCUSCREEN TYPE 1077Gn Otometrics2014-02-27
K131141EARPROBEPath Medical GmbH2013-06-27
K123701HEARLAB ACAFrye Electronics, Inc.2013-04-05
K122067TYPE 1077 ACCUSCREENGn Otometrics2012-09-27
K111555CIRCUMAURAL ADHESIVE REPLACEMENTR & D Medical Products, Inc.2011-07-25
K103760TITANInteracoustics A/S2011-05-05
K100661EARPROBEPath Medical GmbH2010-07-01