Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart B — Neurological Diagnostic Devices](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices) → [21 CFR 882.1900](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1900) → GWJ — Stimulator, Auditory, Evoked Response # GWJ · Stimulator, Auditory, Evoked Response _Neurology · 21 CFR 882.1900 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWJ ## Overview - **Product Code:** GWJ - **Device Name:** Stimulator, Auditory, Evoked Response - **Regulation:** [21 CFR 882.1900](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1900) - **Device Class:** 2 - **Review Panel:** [Neurology](/submissions/NE) - **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). ## Recent Cleared Devices (20 of 76) Showing 20 most recent of 76 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K242954](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWJ/K242954.md) | Integrity V500 (Integrity, Integrity with VEMP) | Vivosonic, Inc. | Dec 19, 2024 | SESE | | [K233649](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWJ/K233649.md) | ALGO Pro Newborn Hearing Screener (ALGO Pro) | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | Mar 8, 2024 | SESE | | [K220139](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWJ/K220139.md) | QScreen | Path Medical GmbH | Aug 3, 2022 | SESE | | [K211147](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWJ/K211147.md) | ALGO 7i | Path Medical GmbH | Oct 14, 2021 | SESE | | [K193033](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWJ/K193033.md) | GSI Audera Pro | Grason Stadler | Apr 24, 2020 | SESE | | [K163326](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWJ/K163326.md) | SmartEP | Intelligent Hearing Systems | Sep 29, 2017 | SESE | | [K162037](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWJ/K162037.md) | Eclipse with VEMP | Interacoustics A/S | Mar 23, 2017 | SESE | | [K143670](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWJ/K143670.md) | ICS CHARTR EP 200 WITH VEMP | Gn Otometrics A/S | Oct 23, 2015 | SESE | | [K141446](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWJ/K141446.md) | 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](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWJ/K132957.md) | MADSEN ACCUSCREEN TYPE 1077 | Gn Otometrics | Feb 27, 2014 | SESE | | [K131141](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWJ/K131141.md) | EARPROBE | Path Medical GmbH | Jun 27, 2013 | SESE | | [K123701](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWJ/K123701.md) | HEARLAB ACA | Frye Electronics, Inc. | Apr 5, 2013 | SESE | | [K122067](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWJ/K122067.md) | TYPE 1077 ACCUSCREEN | Gn Otometrics | Sep 27, 2012 | SESE | | [K111555](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWJ/K111555.md) | CIRCUMAURAL ADHESIVE REPLACEMENT | R & D Medical Products, Inc. | Jul 25, 2011 | SESE | | [K103760](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWJ/K103760.md) | TITAN | Interacoustics A/S | May 5, 2011 | SESE | | [K100661](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWJ/K100661.md) | EARPROBE | Path Medical GmbH | Jul 1, 2010 | SESE | | [K092373](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWJ/K092373.md) | ICS CHARTR EP 200 | Gn Otometrics | Sep 3, 2009 | SESE | | [K090579](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWJ/K090579.md) | SMARTSCREENER-PLUS2 | Intelligent Hearing Systems | Jul 7, 2009 | SESE | | [K083399](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWJ/K083399.md) | ICS CHARTR EP 200 | Gn Otometrics A/S | Feb 20, 2009 | SESE | | [K082035](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWJ/K082035.md) | MAICO MB 11 WITH BERAPHONE PROBE | Maico Diagnostics | Jan 29, 2009 | SESE | ## Top Applicants - Intelligent Hearing Systems — 8 clearances - Bio-Logic Systems Corp. — 7 clearances - Natus Medical, Inc. — 4 clearances - Path Medical GmbH — 4 clearances - Amplaid USA, Inc. — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWJ](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWJ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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