GWJ — Stimulator, Auditory, Evoked Response Class II
FDA product code GWJ covers "Stimulator, Auditory, Evoked Response", a Class II medical device regulated under 21 CFR 882.1900. Submissions are reviewed by the Neurology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GWJ
- Device Class
- Class II
- Regulation Number
- 882.1900
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K242954 | vivosonic | Integrity V500 (Integrity, Integrity with VEMP) | December 19, 2024 |
| K233649 | natus medical incorporated dba excel-tech ltd. (xltek) | ALGO Pro Newborn Hearing Screener (ALGO Pro) | March 8, 2024 |
| K220139 | path medical | QScreen | August 3, 2022 |
| K211147 | path medical | ALGO 7i | October 14, 2021 |
| K193033 | grason stadler | GSI Audera Pro | April 24, 2020 |
| K163326 | intelligent hearing systems | SmartEP | September 29, 2017 |
| K162037 | interacoustics | Eclipse with VEMP | March 23, 2017 |
| K143670 | gn otometrics | ICS CHARTR EP 200 WITH VEMP | October 23, 2015 |
| K141446 | natus medical incorporated | ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO H | August 22, 2014 |
| K132957 | gn otometrics | MADSEN ACCUSCREEN TYPE 1077 | February 27, 2014 |
| K131141 | path medical | EARPROBE | June 27, 2013 |
| K123701 | frye electronics | HEARLAB ACA | April 5, 2013 |
| K122067 | gn otometrics | TYPE 1077 ACCUSCREEN | September 27, 2012 |
| K111555 | r and d medical products | CIRCUMAURAL ADHESIVE REPLACEMENT | July 25, 2011 |
| K103760 | interacoustics | TITAN | May 5, 2011 |
| K100661 | path medical | EARPROBE | July 1, 2010 |
| K092373 | gn otometrics | ICS CHARTR EP 200 | September 3, 2009 |
| K090579 | intelligent hearing systems | SMARTSCREENER-PLUS2 | July 7, 2009 |
| K083399 | gn otometrics | ICS CHARTR EP 200 | February 20, 2009 |
| K082035 | maico diagnostics | MAICO MB 11 WITH BERAPHONE PROBE | January 29, 2009 |