GWJ · Class II · 21 CFR 882.1900

FDA Product Code GWJ: Stimulator, Auditory, Evoked Response

Leading manufacturers include Bio-Logic Systems Corp., Intelligent Hearing Systems and Path Medical GmbH.

76
Total
76
Cleared
114d
Avg days
1977
Since
76 devices
25–48 of 76
Cleared Jul 18, 2007
SMARTEP, MODEL M010000
K070608
Intelligent Hearing Systems
Neurology · 135d
Cleared Jun 29, 2007
INTERACOUSTICS ASSR, ECLIPSE SYSTEM (CABINET NAME)
K070696
Interacoustics A/S
Neurology · 108d
Cleared Jun 23, 2006
SMART USBLITE, MODEL M011120
K061443
Intelligent Hearing Systems
Neurology · 30d
Cleared Jan 24, 2005
INTEGRITY, MODEL V500
K043396
Vivosonic, Inc.
Neurology · 45d
Cleared May 09, 2003
STACKED ABR FOR NAVIGATOR PRO
K030907
Bio-Logic Systems Corp.
Neurology · 46d
Cleared Apr 28, 2003
MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL (EP) SYSTEM
K031009
Bio-Logic Systems Corp.
Neurology · 28d
Cleared Jul 01, 2002
BIO-LOGIC MASTER EVOKED RESPONSE SYSTEM
K021895
Bio-Logic Systems Corp.
Neurology · 21d
Cleared Jun 14, 2002
ECHO-SCREEN T, TA, TD, TDA, TC
K013977
Fischer-Zoth Audiologic Systems, Inc.
Neurology · 193d
Cleared May 15, 2002
BIO-LOGIC ABAER CUB
K021215
Bio-Logic Systems Corp.
Neurology · 28d
Cleared Jan 08, 2002
SABRE COMPAC
K011842
Sle Limited
Neurology · 210d
Cleared Dec 18, 2001
AURIS AEP
K012415
Synapsys, Inc.
Neurology · 141d
Cleared Oct 16, 2001
ALGO 3 NEWBORN HEARING SCREENER
K013137
Natus Medical, Inc.
Neurology · 27d
Cleared Aug 24, 2001
MB 11
K011746
Maico Diagnostic GmbH
Neurology · 79d
Cleared Dec 13, 2000
ICS MEDICAL CHARTR EP AND CHARTR OAE SYSTEMS
K002985
Ics Medical Corp.
Neurology · 79d
Cleared Dec 27, 1999
MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL FOR ABAER/ NAVIGATOR PRO.
K994149
Bio-Logic Systems Corp.
Neurology · 19d
Cleared Nov 16, 1999
SABRE
K993177
Sle Limited
Neurology · 85d
Cleared Oct 25, 1999
INTERACOUSTICS EP 15 ABR STAND ALONE UNIT
K991853
Idem (Int'L Dist. of Electronics For Medicine)
Neurology · 146d
Cleared Sep 14, 1999
BIO-LOGIC EVOKED POTENTIAL FOR ABAER I
K992807
Bio-Logic Systems Corp.
Neurology · 25d
Cleared Jan 30, 1998
EXCEL AV STIM 1000
K972157
Excel Tech. , Ltd.
Neurology · 235d
Cleared Feb 21, 1997
CHARTR EP
K960097
Ics Medical Corp.
Neurology · 407d
Cleared Jan 30, 1992
DANTEC COUNTERPOINT MK2(TM)
K913957
Dantec Medical, Inc.
Neurology · 148d
Cleared Feb 04, 1987
TECA/MEDELEC AS-10 SENSOR
K862906
Teca, Inc.
Neurology · 188d
Cleared Feb 03, 1987
TECA/MEDELEC AUDIOSTAR
K863156
Teca, Inc.
Neurology · 169d
Cleared Jan 29, 1987
EVOPORT 100
K863985
Jedmed Instrument Co.
Neurology · 107d