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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

Decided510(k)Device and applicantCode
Mar 29, 1993K926574MODEL 330 SCREENING AUDIO METER, MODIFIED
Virtual Corp.
GWJ
Jan 30, 1992K913957DANTEC COUNTERPOINT MK2(TM)
Dantec Medical, Inc.
GWJ
Dec 31, 1991K913785CORONET 100
Micro-Shev , Ltd., IL
GWJ
Aug 2, 1991K904926SMART-EP
Intelligent Hearing Systems
GWJ
Jun 7, 1991K905632NICOLET MAPLELEAF SYSTEM
Nicolet Instrument Corp.
GWJ
Mar 21, 1988K874193MICROSHEV MODEL 2000
Micro-Shev , Ltd.
GWJ
Mar 13, 1987K870030THE SCREENER GSI 55 ABR SCREENER
Grason-Stadler, Inc.
GWJ
Feb 4, 1987K862906TECA/MEDELEC AS-10 SENSOR
Teca, Inc.
GWJ
Feb 3, 1987K863156TECA/MEDELEC AUDIOSTAR
Teca, Inc.
GWJ
Jan 29, 1987K863985EVOPORT 100
Jedmed Instrument Co.
GWJ
Sep 26, 1986K862430SIEGEN HEADPHONES
Siegen Corp.
GWJ
Sep 17, 1986K862363INSERT EARPHONES
Cadwell Laboratories, Inc.
GWJ
Sep 17, 1986K86236140-HZ AUDITORY EVOKED RESPONSE TEST
Cadwell Laboratories, Inc.
GWJ
Sep 18, 1985K852687ALGO I
Algotek, Inc.
GWJ
Nov 25, 1983K832510EVOKED POTENTIALS SYSTEM MK10
Amplaid USA, Inc.
GWJ
Mar 8, 1983K830579MULTI-SIGNAL AUDITORY STIMULATOR SM700
Nicolet Biomedical Instruments
GWJ
Aug 25, 1982K822177AUDIOMETERS (VARIOUS MODELS)
Kelleher Corp.
GWJ
Dec 14, 1981K813009TECA VISUAL/AUDIO STIMULATOR MODEL CS-2
Teca, Inc.
GWJ
Apr 29, 1981K810473MK6 ERA SYSTEM
Amplaid USA, Inc.
GWJ
Apr 3, 1981K810138SYNAP-I INFANT SENSORY ASSESSMENT UNIT
Infant Hearing Assessment Foundation
GWJ
Mar 17, 1981K810539MODEL S10CTCM AUDITORY STIMULATOR
Grass Instrument Co.
GWJ
Oct 30, 1979K792085C-ERA-100 COMPUTERIZED ELECTRIC RESPON
Micro-Shev , Ltd.
GWJ
Nov 3, 1978K781667AMPLAID MARK 4 AND MARK 5
Amplaid USA, Inc.
GWJ
Apr 21, 1978K780540ELECTRIC RESPONSE AUDIOMETER
Life-Tech Instruments, Inc.
GWJ
Jun 1, 1977K770878SIGNAL PROCESSOR/AVERAGER MODEL 7S11
Medical Systems Corp.
GWJ
Feb 28, 1977K770268SYS. FOR REC. BSER RESPONSES
Life-Tech Instruments, Inc.
GWJ

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