Product Code: GWJ FDA class 2 21 CFR 882.1900

Stimulator, Auditory, Evoked Response

Neurology

The Stimulator, Auditory, Evoked Response is a neurological diagnostic device that generates precisely controlled auditory stimuli to elicit auditory brainstem responses (ABRs) and other auditory evoked potentials, used to assess hearing and auditory pathway integrity. It is an FDA Class 2 device, indicating moderate risk and requiring 510(k) premarket clearance. The product code is GWJ, regulated under 21 CFR 882.1900 in the Neurology specialty. This device is eligible for third-party 510(k) review.

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FEI Numbers

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Unique Applicants

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Basic Information

Product Code: GWJ
Device Class: FDA class 2
Regulation Number: 882.1900
Medical Specialty: Neurology
Review Panel: NE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 76 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K242954	Integrity V500 (Integrity, Integrity with VEMP)	Dec 19, 2024	Substantially Equivalent	Vivosonic, Inc.
K233649	ALGO Pro Newborn Hearing Screener (ALGO Pro)	Mar 08, 2024	Substantially Equivalent	Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
K220139	QScreen	Aug 03, 2022	Substantially Equivalent	Path Medical GmbH
K211147	ALGO 7i	Oct 14, 2021	Substantially Equivalent	Path Medical GmbH
K193033	GSI Audera Pro	Apr 24, 2020	Substantially Equivalent	Grason Stadler
K163326	SmartEP	Sep 29, 2017	Substantially Equivalent	Intelligent Hearing Systems
K162037	Eclipse with VEMP	Mar 23, 2017	Substantially Equivalent	Interacoustics A/S
K143670	ICS CHARTR EP 200 WITH VEMP	Oct 23, 2015	Substantially Equivalent	Gn Otometrics A/S
K141446	ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO HEARING SCREENER WITHOUT BARCODE SCANNER,	Aug 22, 2014	Substantially Equivalent	Natus Medical Incorporated
K132957	MADSEN ACCUSCREEN TYPE 1077	Feb 27, 2014	Substantially Equivalent	Gn Otometrics
K131141	EARPROBE	Jun 27, 2013	Substantially Equivalent	Path Medical GmbH
K123701	HEARLAB ACA	Apr 05, 2013	Substantially Equivalent	Frye Electronics, Inc.
K122067	TYPE 1077 ACCUSCREEN	Sep 27, 2012	Substantially Equivalent	Gn Otometrics
K111555	CIRCUMAURAL ADHESIVE REPLACEMENT	Jul 25, 2011	Substantially Equivalent	R & D Medical Products, Inc.
K103760	TITAN	May 05, 2011	Substantially Equivalent	Interacoustics A/S
K100661	EARPROBE	Jul 01, 2010	Substantially Equivalent	Path Medical GmbH
K092373	ICS CHARTR EP 200	Sep 03, 2009	Substantially Equivalent	Gn Otometrics
K090579	SMARTSCREENER-PLUS2	Jul 07, 2009	Substantially Equivalent	Intelligent Hearing Systems
K083399	ICS CHARTR EP 200	Feb 20, 2009	Substantially Equivalent	Gn Otometrics A/S
K082035	MAICO MB 11 WITH BERAPHONE PROBE	Jan 29, 2009	Substantially Equivalent	Maico Diagnostics
K080060	VIVOSONIC NEUROSCREEN	Apr 04, 2008	Substantially Equivalent	Vivosonic, Inc.
K073384	SMART COUPLER, MODEL M015401	Feb 28, 2008	Substantially Equivalent	Intelligent Hearing Systems
K073626	BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEM	Feb 05, 2008	Substantially Equivalent	Bio-Logic Systems Corp.
K073665	ALGO 5 NEWBORN HEARING SCREENER	Jan 25, 2008	Substantially Equivalent	Natus Medical, Inc.
K070608	SMARTEP, MODEL M010000	Jul 18, 2007	Substantially Equivalent	Intelligent Hearing Systems
K070696	INTERACOUSTICS ASSR, ECLIPSE SYSTEM (CABINET NAME)	Jun 29, 2007	Substantially Equivalent	Interacoustics A/S
K061443	SMART USBLITE, MODEL M011120	Jun 23, 2006	Substantially Equivalent	Intelligent Hearing Systems
K043396	INTEGRITY, MODEL V500	Jan 24, 2005	Substantially Equivalent	Vivosonic, Inc.
K031051	SMARTEP-ASSR, MODEL M811007	Feb 20, 2004	Substantially Equivalent	Intelligent Hearing Systems
K030907	STACKED ABR FOR NAVIGATOR PRO	May 09, 2003	Substantially Equivalent	Bio-Logic Systems Corp.
K031009	MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL (EP) SYSTEM	Apr 28, 2003	Substantially Equivalent	Bio-Logic Systems Corp.
K030823	ALGO 3I NEWBORN HEARING SCREENER	Apr 09, 2003	Substantially Equivalent	Natus Medical, Inc.
K021895	BIO-LOGIC MASTER EVOKED RESPONSE SYSTEM	Jul 01, 2002	Substantially Equivalent	Bio-Logic Systems Corp.
K013977	ECHO-SCREEN T, TA, TD, TDA, TC	Jun 14, 2002	Substantially Equivalent	Fischer-Zoth Audiologic Systems, Inc.
K021215	BIO-LOGIC ABAER CUB	May 15, 2002	Substantially Equivalent	Bio-Logic Systems Corp.
K011842	SABRE COMPAC	Jan 08, 2002	Substantially Equivalent	Sle Limited
K012415	AURIS AEP	Dec 18, 2001	Substantially Equivalent	Synapsys, Inc.
K013137	ALGO 3 NEWBORN HEARING SCREENER	Oct 16, 2001	Substantially Equivalent	Natus Medical, Inc.
K011746	MB 11	Aug 24, 2001	Substantially Equivalent	Maico Diagnostic GmbH
K002985	ICS MEDICAL CHARTR EP AND CHARTR OAE SYSTEMS	Dec 13, 2000	Substantially Equivalent	Ics Medical Corp.
K994149	MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL FOR ABAER/ NAVIGATOR PRO.	Dec 27, 1999	Substantially Equivalent	Bio-Logic Systems Corp.
K993177	SABRE	Nov 16, 1999	Substantially Equivalent	Sle Limited
K991853	INTERACOUSTICS EP 15 ABR STAND ALONE UNIT	Oct 25, 1999	Substantially Equivalent	Idem (Int'L Dist. of Electronics For Medicine)
K992807	BIO-LOGIC EVOKED POTENTIAL FOR ABAER I	Sep 14, 1999	Substantially Equivalent	Bio-Logic Systems Corp.
K972157	EXCEL AV STIM 1000	Jan 30, 1998	Substantially Equivalent	Excel Tech. , Ltd.
K960097	CHARTR EP	Feb 21, 1997	Substantially Equivalent	Ics Medical Corp.
K953732	TECA PREMIERE	Oct 19, 1995	Substantially Equivalent	Medelec , Ltd.
K952080	CLARITY SYSTEM II	Sep 19, 1995	Substantially Equivalent	Sonamed Corp.
K936039	ALGO-2 NEWBORN HEARING SCREENER	Jan 05, 1995	Substantially Equivalent	Natus Medical, Inc.
K925648	SMART-SCREENER (AUDITORY)	May 11, 1993	Substantially Equivalent	Intelligent Hearing Systems
K926574	MODEL 330 SCREENING AUDIO METER, MODIFIED	Mar 29, 1993	Substantially Equivalent	Virtual Corp.
K913957	DANTEC COUNTERPOINT MK2(TM)	Jan 30, 1992	Substantially Equivalent	Dantec Medical, Inc.
K913785	CORONET 100	Dec 31, 1991	Substantially Equivalent	Micro-Shev , Ltd.
K904926	SMART-EP	Aug 02, 1991	Substantially Equivalent	Intelligent Hearing Systems
K905632	NICOLET MAPLELEAF SYSTEM	Jun 07, 1991	Substantially Equivalent	Nicolet Instrument Corp.
K874193	MICROSHEV MODEL 2000	Mar 21, 1988	Substantially Equivalent	Micro-Shev , Ltd.
K870030	THE SCREENER GSI 55 ABR SCREENER	Mar 13, 1987	Substantially Equivalent	Grason-Stadler, Inc.
K862906	TECA/MEDELEC AS-10 SENSOR	Feb 04, 1987	Substantially Equivalent	Teca, Inc.
K863156	TECA/MEDELEC AUDIOSTAR	Feb 03, 1987	Substantially Equivalent	Teca, Inc.
K863985	EVOPORT 100	Jan 29, 1987	Substantially Equivalent	Jedmed Instrument Co.
K862430	SIEGEN HEADPHONES	Sep 26, 1986	Substantially Equivalent	Siegen Corp.
K862363	INSERT EARPHONES	Sep 17, 1986	Substantially Equivalent	Cadwell Laboratories, Inc.
K862361	40-HZ AUDITORY EVOKED RESPONSE TEST	Sep 17, 1986	Substantially Equivalent	Cadwell Laboratories, Inc.
K852687	ALGO I	Sep 18, 1985	Substantially Equivalent	Algotek, Inc.
K832510	EVOKED POTENTIALS SYSTEM MK10	Nov 25, 1983	Substantially Equivalent	Amplaid USA, Inc.
K830579	MULTI-SIGNAL AUDITORY STIMULATOR SM700	Mar 08, 1983	Substantially Equivalent	Nicolet Biomedical Instruments
K822177	AUDIOMETERS (VARIOUS MODELS)	Aug 25, 1982	Substantially Equivalent	Kelleher Corp.
K813009	TECA VISUAL/AUDIO STIMULATOR MODEL CS-2	Dec 14, 1981	Substantially Equivalent	Teca, Inc.
K810473	MK6 ERA SYSTEM	Apr 29, 1981	Substantially Equivalent	Amplaid USA, Inc.
K810138	SYNAP-I INFANT SENSORY ASSESSMENT UNIT	Apr 03, 1981	Substantially Equivalent	Infant Hearing Assessment Foundation
K810539	MODEL S10CTCM AUDITORY STIMULATOR	Mar 17, 1981	Substantially Equivalent	Grass Instrument Co.
K792085	C-ERA-100 COMPUTERIZED ELECTRIC RESPON	Oct 30, 1979	Substantially Equivalent	Micro-Shev , Ltd.
K781667	AMPLAID MARK 4 AND MARK 5	Nov 03, 1978	Substantially Equivalent	Amplaid USA, Inc.
K780540	ELECTRIC RESPONSE AUDIOMETER	Apr 21, 1978	Substantially Equivalent	Life-Tech Instruments, Inc.
K770878	SIGNAL PROCESSOR/AVERAGER MODEL 7S11	Jun 01, 1977	Substantially Equivalent	Medical Systems Corp.
K770268	SYS. FOR REC. BSER RESPONSES	Feb 28, 1977	Substantially Equivalent	Life-Tech Instruments, Inc.