Product code GWJ
- Device name
- Stimulator, Auditory, Evoked Response
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.1900
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242954 | Integrity V500 (Integrity, Integrity with VEMP) | Vivosonic, Inc. | 2024-12-19 |
| K233649 | ALGO Pro Newborn Hearing Screener (ALGO Pro) | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2024-03-08 |
| K220139 | QScreen | Path Medical GmbH | 2022-08-03 |
| K211147 | ALGO 7i | Path Medical GmbH | 2021-10-14 |
| K193033 | GSI Audera Pro | Grason Stadler | 2020-04-24 |
| K163326 | SmartEP | Intelligent Hearing Systems | 2017-09-29 |
| K162037 | Eclipse with VEMP | Interacoustics A/S | 2017-03-23 |
| K143670 | ICS CHARTR EP 200 WITH VEMP | Gn Otometrics A/S | 2015-10-23 |
| K141446 | ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO HEARING SCREENER WITHOUT BARCODE SCANNER, | Natus Medical Incorporated | 2014-08-22 |
| K132957 | MADSEN ACCUSCREEN TYPE 1077 | Gn Otometrics | 2014-02-27 |
| K131141 | EARPROBE | Path Medical GmbH | 2013-06-27 |
| K123701 | HEARLAB ACA | Frye Electronics, Inc. | 2013-04-05 |
| K122067 | TYPE 1077 ACCUSCREEN | Gn Otometrics | 2012-09-27 |
| K111555 | CIRCUMAURAL ADHESIVE REPLACEMENT | R & D Medical Products, Inc. | 2011-07-25 |
| K103760 | TITAN | Interacoustics A/S | 2011-05-05 |
| K100661 | EARPROBE | Path Medical GmbH | 2010-07-01 |
| K092373 | ICS CHARTR EP 200 | Gn Otometrics | 2009-09-03 |
| K090579 | SMARTSCREENER-PLUS2 | Intelligent Hearing Systems | 2009-07-07 |
| K083399 | ICS CHARTR EP 200 | Gn Otometrics A/S | 2009-02-20 |
| K082035 | MAICO MB 11 WITH BERAPHONE PROBE | Maico Diagnostics | 2009-01-29 |
| K080060 | VIVOSONIC NEUROSCREEN | Vivosonic, Inc. | 2008-04-04 |
| K073384 | SMART COUPLER, MODEL M015401 | Intelligent Hearing Systems | 2008-02-28 |
| K073626 | BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEM | Bio-Logic Systems Corp. | 2008-02-05 |
| K073665 | ALGO 5 NEWBORN HEARING SCREENER | Natus Medical, Inc. | 2008-01-25 |
| K070608 | SMARTEP, MODEL M010000 | Intelligent Hearing Systems | 2007-07-18 |
| K070696 | INTERACOUSTICS ASSR, ECLIPSE SYSTEM (CABINET NAME) | Interacoustics A/S | 2007-06-29 |
| K061443 | SMART USBLITE, MODEL M011120 | Intelligent Hearing Systems | 2006-06-23 |
| K043396 | INTEGRITY, MODEL V500 | Vivosonic, Inc. | 2005-01-24 |
| K031051 | SMARTEP-ASSR, MODEL M811007 | Intelligent Hearing Systems | 2004-02-20 |
| K030907 | STACKED ABR FOR NAVIGATOR PRO | Bio-Logic Systems Corp. | 2003-05-09 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08056446901205 | NExT Station | EB NEURO SPA | 2025-05-22 |
| 08056446901199 | NExT-AS | EB NEURO SPA | 2025-05-22 |
| 08056446901168 | NExT-AMP | EB NEURO SPA | 2025-05-22 |
| 08056446901137 | NExT-HS | EB NEURO SPA | 2025-05-22 |
| 08056446901120 | NExT-AMP-ADVANCED | EB NEURO SPA | 2025-05-22 |
| 08056446901113 | NExT-PAD | EB NEURO SPA | 2025-05-22 |
| 08056446901106 | NExT-DOCKING | EB NEURO SPA | 2025-05-22 |
| 08056446901090 | NExT Station Advanced | EB NEURO SPA | 2025-05-19 |
| 00817020021126 | Aria | INTELLIGENT HEARING SYSTEMS CORP. | 2024-03-11 |
| 08056446900642 | Galileo NT Line Software | EB NEURO SPA | 2020-05-25 |
| 08056446900260 | R-KEY (Dedicated Keyboard) | EB NEURO SPA | 2019-05-24 |
| 08056446900246 | Power-LAN Connection Box | EB NEURO SPA | 2019-05-24 |
| 08056446900239 | NeMus 1 | EB NEURO SPA | 2019-05-24 |
| 08056446900222 | NeMus 1 | EB NEURO SPA | 2019-05-24 |
| 08056446900215 | NeMus PC PERIPHERAL | EB NEURO SPA | 2019-05-24 |
| 08056446900208 | NeMus SYSTEM | EB NEURO SPA | 2019-05-24 |
| 08056446900253 | Power-LAN Connection Box USB | EB NEURO SPA | 2019-04-10 |
| 08584270041304 | Maico | Diagnostic Group LLC | 2016-11-10 |
| 08584270041076 | Grason-Stadler | Diagnostic Group LLC | 2016-11-10 |
| 00817020020013 | EarHug Pack | INTELLIGENT HEARING SYSTEMS CORP. | 2016-09-24 |
| 08584270041618 | Maico | Diagnostic Group LLC | 2016-09-24 |
| 20613994327820 | N/A | MEDTRONIC XOMED, INC. | 2016-07-01 |
| 20613994330059 | N/A | MEDTRONIC SOFAMOR DANEK, INC. | 2016-07-01 |
| 20613994801528 | NA | MEDTRONIC XOMED, INC. | 2016-05-01 |
| 20613994802266 | NA | MEDTRONIC XOMED, INC. | 2016-05-01 |
| 20613994801405 | NA | MEDTRONIC XOMED, INC. | 2016-04-30 |
| 20613994801511 | NA | MEDTRONIC XOMED, INC. | 2016-04-30 |
| 20613994801535 | NA | MEDTRONIC XOMED, INC. | 2016-04-30 |
| 20613994802259 | NA | MEDTRONIC XOMED, INC. | 2016-04-30 |
| 20613994802273 | NA | MEDTRONIC XOMED, INC. | 2016-04-30 |