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Panels › Neurology › Product code GWJ · Class 2

Stimulator, Auditory, Evoked Response

Regulation 882.1900

0510(k)s in 12 months (76 all time)
1recalls in 12 months (4 all time)
3recalls that name a 510(k)
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Top companies in GWJ

Company510(k)sRecalls
Intelligent Hearing Systems81
Bio-Logic Systems Corp.70
Natus Medical Incorporated51
Gn Otometrics31
Path Medical GmbH40
Amplaid USA, Inc.30
Interacoustics A/S30
Micro-Shev , Ltd.30
Teca, Inc.30
Vivosonic, Inc.30
DateFirm and productCodeLinked 510(k)
Dec 18, 2025PATH
MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)
Open, Classified		 GWJK100661
May 28, 2019GN Otometrics
The ICS CHARTR EP 200
Terminated		 GWJK083399
Aug 3, 2010Natus Medical Inc
SonaMed Clarity System II; evoked response auditory stimulator; SonaMed Corp., Waltham, MA 02154
Terminated		 GWJK952080
May 27, 2010Intelligent Hearing Systems Corp.
Intelligent Hearing Systems Corporation, SmartEP with Vestibular Evoked Myogenic Potentials Version 3.96. Model M811016
Terminated		 GWJNone listed

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