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).
Recent Cleared Devices (20 of 76)
Showing 20 most recent of 76 cleared devices.
| 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 |
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
