GWJ · Stimulator, Auditory, Evoked Response
Neurology · 21 CFR 882.1900 · Class 2
Overview
| Product Code | GWJ |
|---|---|
| Device Name | Stimulator, Auditory, Evoked Response |
| Regulation | 21 CFR 882.1900 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 3rd-Party Reviewable | Yes |
Identification
An evoked response auditory stimulator is a device that produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.
Classification Rationale
Class II (performance standards).
Cleared Devices (76)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K242954 | Integrity V500 (Integrity, Integrity with VEMP) | Vivosonic, Inc. | Dec 19, 2024 | SESE |
| K233649 | ALGO Pro Newborn Hearing Screener (ALGO Pro) | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | Mar 8, 2024 | SESE |
| K220139 | QScreen | Path Medical GmbH | Aug 3, 2022 | SESE |
| K211147 | ALGO 7i | Path Medical GmbH | Oct 14, 2021 | SESE |
| K193033 | GSI Audera Pro | Grason Stadler | Apr 24, 2020 | SESE |
| K163326 | SmartEP | Intelligent Hearing Systems | Sep 29, 2017 | SESE |
| K162037 | Eclipse with VEMP | Interacoustics A/S | Mar 23, 2017 | SESE |
| K143670 | ICS CHARTR EP 200 WITH VEMP | Gn Otometrics A/S | Oct 23, 2015 | SESE |
| K141446 | ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO HEARING SCREENER WITHOUT BARCODE SCANNER, | Natus Medical Incorporated | Aug 22, 2014 | SESE |
| K132957 | MADSEN ACCUSCREEN TYPE 1077 | Gn Otometrics | Feb 27, 2014 | SESE |
| K131141 | EARPROBE | Path Medical GmbH | Jun 27, 2013 | SESE |
| K123701 | HEARLAB ACA | Frye Electronics, Inc. | Apr 5, 2013 | SESE |
| K122067 | TYPE 1077 ACCUSCREEN | Gn Otometrics | Sep 27, 2012 | SESE |
| K111555 | CIRCUMAURAL ADHESIVE REPLACEMENT | R & D Medical Products, Inc. | Jul 25, 2011 | SESE |
| K103760 | TITAN | Interacoustics A/S | May 5, 2011 | SESE |
| K100661 | EARPROBE | Path Medical GmbH | Jul 1, 2010 | SESE |
| K092373 | ICS CHARTR EP 200 | Gn Otometrics | Sep 3, 2009 | SESE |
| K090579 | SMARTSCREENER-PLUS2 | Intelligent Hearing Systems | Jul 7, 2009 | SESE |
| K083399 | ICS CHARTR EP 200 | Gn Otometrics A/S | Feb 20, 2009 | SESE |
| K082035 | MAICO MB 11 WITH BERAPHONE PROBE | Maico Diagnostics | Jan 29, 2009 | SESE |
| K080060 | VIVOSONIC NEUROSCREEN | Vivosonic, Inc. | Apr 4, 2008 | SESE |
| K073384 | SMART COUPLER, MODEL M015401 | Intelligent Hearing Systems | Feb 28, 2008 | SESE |
| K073626 | BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEM | Bio-Logic Systems Corp. | Feb 5, 2008 | SESE |
| K073665 | ALGO 5 NEWBORN HEARING SCREENER | Natus Medical, Inc. | Jan 25, 2008 | SESE |
| K070608 | SMARTEP, MODEL M010000 | Intelligent Hearing Systems | Jul 18, 2007 | SESE |
| K070696 | INTERACOUSTICS ASSR, ECLIPSE SYSTEM (CABINET NAME) | Interacoustics A/S | Jun 29, 2007 | SESE |
| K061443 | SMART USBLITE, MODEL M011120 | Intelligent Hearing Systems | Jun 23, 2006 | SESE |
| K043396 | INTEGRITY, MODEL V500 | Vivosonic, Inc. | Jan 24, 2005 | SESE |
| K031051 | SMARTEP-ASSR, MODEL M811007 | Intelligent Hearing Systems | Feb 20, 2004 | SESE |
| K030907 | STACKED ABR FOR NAVIGATOR PRO | Bio-Logic Systems Corp. | May 9, 2003 | SESE |
| K031009 | MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL (EP) SYSTEM | Bio-Logic Systems Corp. | Apr 28, 2003 | SESE |
| K030823 | ALGO 3I NEWBORN HEARING SCREENER | Natus Medical, Inc. | Apr 9, 2003 | SESE |
| K021895 | BIO-LOGIC MASTER EVOKED RESPONSE SYSTEM | Bio-Logic Systems Corp. | Jul 1, 2002 | SESE |
| K013977 | ECHO-SCREEN T, TA, TD, TDA, TC | Fischer-Zoth Audiologic Systems, Inc. | Jun 14, 2002 | SESE |
| K021215 | BIO-LOGIC ABAER CUB | Bio-Logic Systems Corp. | May 15, 2002 | SESE |
| K011842 | SABRE COMPAC | Sle Limited | Jan 8, 2002 | SESE |
| K012415 | AURIS AEP | Synapsys, Inc. | Dec 18, 2001 | SESE |
| K013137 | ALGO 3 NEWBORN HEARING SCREENER | Natus Medical, Inc. | Oct 16, 2001 | SESE |
| K011746 | MB 11 | Maico Diagnostic GmbH | Aug 24, 2001 | SESE |
| K002985 | ICS MEDICAL CHARTR EP AND CHARTR OAE SYSTEMS | Ics Medical Corp. | Dec 13, 2000 | SESE |
| K994149 | MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL FOR ABAER/ NAVIGATOR PRO. | Bio-Logic Systems Corp. | Dec 27, 1999 | SESE |
| K993177 | SABRE | Sle Limited | Nov 16, 1999 | SESE |
| K991853 | INTERACOUSTICS EP 15 ABR STAND ALONE UNIT | Idem (Int'L Dist. of Electronics For Medicine) | Oct 25, 1999 | SESE |
| K992807 | BIO-LOGIC EVOKED POTENTIAL FOR ABAER I | Bio-Logic Systems Corp. | Sep 14, 1999 | SESE |
| K972157 | EXCEL AV STIM 1000 | Excel Tech. , Ltd. | Jan 30, 1998 | SESE |
| K960097 | CHARTR EP | Ics Medical Corp. | Feb 21, 1997 | SESE |
| K953732 | TECA PREMIERE | Medelec , Ltd. | Oct 19, 1995 | SESE |
| K952080 | CLARITY SYSTEM II | Sonamed Corp. | Sep 19, 1995 | SESE |
| K936039 | ALGO-2 NEWBORN HEARING SCREENER | Natus Medical, Inc. | Jan 5, 1995 | SESE |
| K925648 | SMART-SCREENER (AUDITORY) | Intelligent Hearing Systems | May 11, 1993 | SESE |
| K926574 | MODEL 330 SCREENING AUDIO METER, MODIFIED | Virtual Corp. | Mar 29, 1993 | SESE |
| K913957 | DANTEC COUNTERPOINT MK2(TM) | Dantec Medical, Inc. | Jan 30, 1992 | SESE |
| K913785 | CORONET 100 | Micro-Shev , Ltd. | Dec 31, 1991 | SESE |
| K904926 | SMART-EP | Intelligent Hearing Systems | Aug 2, 1991 | SESE |
| K905632 | NICOLET MAPLELEAF SYSTEM | Nicolet Instrument Corp. | Jun 7, 1991 | SESE |
| K874193 | MICROSHEV MODEL 2000 | Micro-Shev , Ltd. | Mar 21, 1988 | SESE |
| K870030 | THE SCREENER GSI 55 ABR SCREENER | Grason-Stadler, Inc. | Mar 13, 1987 | SESE |
| K862906 | TECA/MEDELEC AS-10 SENSOR | Teca, Inc. | Feb 4, 1987 | SESE |
| K863156 | TECA/MEDELEC AUDIOSTAR | Teca, Inc. | Feb 3, 1987 | SESE |
| K863985 | EVOPORT 100 | Jedmed Instrument Co. | Jan 29, 1987 | SESE |
| K862430 | SIEGEN HEADPHONES | Siegen Corp. | Sep 26, 1986 | SESE |
| K862363 | INSERT EARPHONES | Cadwell Laboratories, Inc. | Sep 17, 1986 | SESE |
| K862361 | 40-HZ AUDITORY EVOKED RESPONSE TEST | Cadwell Laboratories, Inc. | Sep 17, 1986 | SESE |
| K852687 | ALGO I | Algotek, Inc. | Sep 18, 1985 | SESE |
| K832510 | EVOKED POTENTIALS SYSTEM MK10 | Amplaid USA, Inc. | Nov 25, 1983 | SESE |
| K830579 | MULTI-SIGNAL AUDITORY STIMULATOR SM700 | Nicolet Biomedical Instruments | Mar 8, 1983 | SESE |
| K822177 | AUDIOMETERS (VARIOUS MODELS) | Kelleher Corp. | Aug 25, 1982 | SESE |
| K813009 | TECA VISUAL/AUDIO STIMULATOR MODEL CS-2 | Teca, Inc. | Dec 14, 1981 | SESE |
| K810473 | MK6 ERA SYSTEM | Amplaid USA, Inc. | Apr 29, 1981 | SESE |
| K810138 | SYNAP-I INFANT SENSORY ASSESSMENT UNIT | Infant Hearing Assessment Foundation | Apr 3, 1981 | SESE |
| K810539 | MODEL S10CTCM AUDITORY STIMULATOR | Grass Instrument Co. | Mar 17, 1981 | SESE |
| K792085 | C-ERA-100 COMPUTERIZED ELECTRIC RESPON | Micro-Shev , Ltd. | Oct 30, 1979 | SESE |
| K781667 | AMPLAID MARK 4 AND MARK 5 | Amplaid USA, Inc. | Nov 3, 1978 | SESE |
| K780540 | ELECTRIC RESPONSE AUDIOMETER | Life-Tech Instruments, Inc. | Apr 21, 1978 | SESE |
| K770878 | SIGNAL PROCESSOR/AVERAGER MODEL 7S11 | Medical Systems Corp. | Jun 1, 1977 | SESE |
| K770268 | SYS. FOR REC. BSER RESPONSES | Life-Tech Instruments, Inc. | Feb 28, 1977 | SESE |
Top Applicants
- Intelligent Hearing Systems — 8 clearances
- Bio-Logic Systems Corp. — 7 clearances
- Path Medical GmbH — 4 clearances
- Natus Medical, Inc. — 4 clearances
- Vivosonic, Inc. — 3 clearances
