Stimulator, Auditory, Evoked Response

FDA product code GWJ · 73 cleared devices

Class 2 Neurology

Regulation: 21 CFR 882.1900
Review panel: NE
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-02-28 – 2024-12-19

GWJ 2024-12-19

Integrity V500 (Integrity, Integrity with VEMP)

Applicant Vivosonic, Inc.

K number K242954

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GWJ 2024-03-08

ALGO Pro Newborn Hearing Screener (ALGO Pro)

Applicant Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)

K number K233649

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GWJ 2022-08-03

QScreen

Applicant Path Medical GmbH

K number K220139

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GWJ 2021-10-14

ALGO 7i

Applicant Path Medical GmbH

K number K211147

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GWJ 2020-04-24

GSI Audera Pro

Applicant Grason Stadler

K number K193033

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GWJ 2017-09-29

SmartEP

Applicant Intelligent Hearing Systems

K number K163326

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GWJ 2017-03-23

Eclipse with VEMP

Applicant Interacoustics A/S

K number K162037

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GWJ 2013-06-27

EARPROBE

Applicant Path Medical GmbH

K number K131141

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GWJ 2013-04-05

HEARLAB ACA

Applicant Frye Electronics, Inc.

K number K123701

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GWJ 2012-09-27

TYPE 1077 ACCUSCREEN

Applicant Gn Otometrics

K number K122067

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GWJ 2011-07-25

CIRCUMAURAL ADHESIVE REPLACEMENT

Applicant R & D Medical Products, Inc.

K number K111555

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GWJ 2011-05-05

TITAN

Applicant Interacoustics A/S

K number K103760

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GWJ 2010-07-01

EARPROBE

Applicant Path Medical GmbH

K number K100661

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GWJ 2009-09-03

ICS CHARTR EP 200

Applicant Gn Otometrics

K number K092373

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GWJ 2009-07-07

SMARTSCREENER-PLUS2

Applicant Intelligent Hearing Systems

K number K090579

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GWJ 2009-02-20

ICS CHARTR EP 200

Applicant Gn Otometrics A/S

K number K083399

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GWJ 2009-01-29

MAICO MB 11 WITH BERAPHONE PROBE

Applicant Maico Diagnostics

K number K082035

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GWJ 2008-04-04

VIVOSONIC NEUROSCREEN

Applicant Vivosonic, Inc.

K number K080060

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GWJ 2008-02-28

SMART COUPLER, MODEL M015401

Applicant Intelligent Hearing Systems

K number K073384

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GWJ 2008-02-05

BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEM

Applicant Bio-Logic Systems Corp.

K number K073626

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GWJ 2008-01-25

ALGO 5 NEWBORN HEARING SCREENER

Applicant Natus Medical, Inc.

K number K073665

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GWJ 2007-07-18

SMARTEP, MODEL M010000

Applicant Intelligent Hearing Systems

K number K070608

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GWJ 2007-06-29

INTERACOUSTICS ASSR, ECLIPSE SYSTEM (CABINET NAME)

Applicant Interacoustics A/S

K number K070696

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GWJ 2006-06-23

SMART USBLITE, MODEL M011120

Applicant Intelligent Hearing Systems

K number K061443

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GWJ 2005-01-24

INTEGRITY, MODEL V500

Applicant Vivosonic, Inc.

K number K043396

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GWJ 2004-02-20

SMARTEP-ASSR, MODEL M811007

Applicant Intelligent Hearing Systems

K number K031051

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GWJ 2003-05-09

STACKED ABR FOR NAVIGATOR PRO

Applicant Bio-Logic Systems Corp.

K number K030907

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GWJ 2003-04-28

MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL (EP) SYSTEM

Applicant Bio-Logic Systems Corp.

K number K031009

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GWJ 2003-04-09

ALGO 3I NEWBORN HEARING SCREENER

Applicant Natus Medical, Inc.

K number K030823

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GWJ 2002-07-01

BIO-LOGIC MASTER EVOKED RESPONSE SYSTEM

Applicant Bio-Logic Systems Corp.

K number K021895

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GWJ 2002-06-14

ECHO-SCREEN T, TA, TD, TDA, TC

Applicant Fischer-Zoth Audiologic Systems, Inc.

K number K013977

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GWJ 2002-05-15

BIO-LOGIC ABAER CUB

Applicant Bio-Logic Systems Corp.

K number K021215

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GWJ 2002-01-08

SABRE COMPAC

Applicant Sle Limited

K number K011842

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GWJ 2001-12-18

AURIS AEP

Applicant Synapsys, Inc.

K number K012415

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GWJ 2001-10-16

ALGO 3 NEWBORN HEARING SCREENER

Applicant Natus Medical, Inc.

K number K013137

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GWJ 2001-08-24

MB 11

Applicant Maico Diagnostic GmbH

K number K011746

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GWJ 2000-12-13

ICS MEDICAL CHARTR EP AND CHARTR OAE SYSTEMS

Applicant Ics Medical Corp.

K number K002985

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GWJ 1999-12-27

MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL FOR ABAER/ NAVIGATOR PRO.

Applicant Bio-Logic Systems Corp.

K number K994149

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GWJ 1999-11-16

SABRE

Applicant Sle Limited

K number K993177

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GWJ 1999-10-25

INTERACOUSTICS EP 15 ABR STAND ALONE UNIT

Applicant Idem (Int'L Dist. of Electronics For Medicine)

K number K991853

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GWJ 1999-09-14

BIO-LOGIC EVOKED POTENTIAL FOR ABAER I

Applicant Bio-Logic Systems Corp.

K number K992807

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GWJ 1998-01-30

EXCEL AV STIM 1000

Applicant Excel Tech. , Ltd.

K number K972157

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GWJ 1997-02-21

CHARTR EP

Applicant Ics Medical Corp.

K number K960097

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GWJ 1995-10-19

TECA PREMIERE

Applicant Medelec , Ltd.

K number K953732

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GWJ 1995-09-19

CLARITY SYSTEM II

Applicant Sonamed Corp.

K number K952080

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GWJ 1995-01-05

ALGO-2 NEWBORN HEARING SCREENER

Applicant Natus Medical, Inc.

K number K936039

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GWJ 1993-05-11

SMART-SCREENER (AUDITORY)

Applicant Intelligent Hearing Systems

K number K925648

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GWJ 1993-03-29

MODEL 330 SCREENING AUDIO METER, MODIFIED

Applicant Virtual Corp.

K number K926574

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GWJ 1992-01-30

DANTEC COUNTERPOINT MK2(TM)

Applicant Dantec Medical, Inc.

K number K913957

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GWJ 1991-12-31

CORONET 100

Applicant Micro-Shev , Ltd.

K number K913785

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GWJ 1991-08-02

SMART-EP

Applicant Intelligent Hearing Systems

K number K904926

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GWJ 1991-06-07

NICOLET MAPLELEAF SYSTEM

Applicant Nicolet Instrument Corp.

K number K905632

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GWJ 1988-03-21

MICROSHEV MODEL 2000

Applicant Micro-Shev , Ltd.

K number K874193

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GWJ 1987-03-13

THE SCREENER GSI 55 ABR SCREENER

Applicant Grason-Stadler, Inc.

K number K870030

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GWJ 1987-02-04

TECA/MEDELEC AS-10 SENSOR

Applicant Teca, Inc.

K number K862906

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GWJ 1987-02-03

TECA/MEDELEC AUDIOSTAR

Applicant Teca, Inc.

K number K863156

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GWJ 1987-01-29

EVOPORT 100

Applicant Jedmed Instrument Co.

K number K863985

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GWJ 1986-09-26

SIEGEN HEADPHONES

Applicant Siegen Corp.

K number K862430

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GWJ 1986-09-17

INSERT EARPHONES

Applicant Cadwell Laboratories, Inc.

K number K862363

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GWJ 1986-09-17

40-HZ AUDITORY EVOKED RESPONSE TEST

Applicant Cadwell Laboratories, Inc.

K number K862361

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GWJ 1985-09-18

ALGO I

Applicant Algotek, Inc.

K number K852687

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GWJ 1983-11-25

EVOKED POTENTIALS SYSTEM MK10

Applicant Amplaid USA, Inc.

K number K832510

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GWJ 1983-03-08

MULTI-SIGNAL AUDITORY STIMULATOR SM700

Applicant Nicolet Biomedical Instruments

K number K830579

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GWJ 1982-08-25

AUDIOMETERS (VARIOUS MODELS)

Applicant Kelleher Corp.

K number K822177

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GWJ 1981-12-14

TECA VISUAL/AUDIO STIMULATOR MODEL CS-2

Applicant Teca, Inc.

K number K813009

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GWJ 1981-04-29

MK6 ERA SYSTEM

Applicant Amplaid USA, Inc.

K number K810473

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GWJ 1981-04-03

SYNAP-I INFANT SENSORY ASSESSMENT UNIT

Applicant Infant Hearing Assessment Foundation

K number K810138

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GWJ 1981-03-17

MODEL S10CTCM AUDITORY STIMULATOR

Applicant Grass Instrument Co.

K number K810539

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GWJ 1979-10-30

C-ERA-100 COMPUTERIZED ELECTRIC RESPON

Applicant Micro-Shev , Ltd.

K number K792085

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GWJ 1978-11-03

AMPLAID MARK 4 AND MARK 5

Applicant Amplaid USA, Inc.

K number K781667

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GWJ 1978-04-21

ELECTRIC RESPONSE AUDIOMETER

Applicant Life-Tech Instruments, Inc.

K number K780540

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GWJ 1977-06-01

SIGNAL PROCESSOR/AVERAGER MODEL 7S11

Applicant Medical Systems Corp.

K number K770878

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GWJ 1977-02-28

SYS. FOR REC. BSER RESPONSES

Applicant Life-Tech Instruments, Inc.

K number K770268

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