Home / Device Classification / GWJ

GWJ — Stimulator, Auditory, Evoked Response Class II

FDA Device Classification

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-NumberApplicantDevice NameDate
K242954vivosonicIntegrity V500 (Integrity, Integrity with VEMP)December 19, 2024
K233649natus medical incorporated dba excel-tech ltd. (xltek)ALGO Pro Newborn Hearing Screener (ALGO Pro)March 8, 2024
K220139path medicalQScreenAugust 3, 2022
K211147path medicalALGO 7iOctober 14, 2021
K193033grason stadlerGSI Audera ProApril 24, 2020
K163326intelligent hearing systemsSmartEPSeptember 29, 2017
K162037interacousticsEclipse with VEMPMarch 23, 2017
K143670gn otometricsICS CHARTR EP 200 WITH VEMPOctober 23, 2015
K141446natus medical incorporatedECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO HAugust 22, 2014
K132957gn otometricsMADSEN ACCUSCREEN TYPE 1077February 27, 2014
K131141path medicalEARPROBEJune 27, 2013
K123701frye electronicsHEARLAB ACAApril 5, 2013
K122067gn otometricsTYPE 1077 ACCUSCREENSeptember 27, 2012
K111555r and d medical productsCIRCUMAURAL ADHESIVE REPLACEMENTJuly 25, 2011
K103760interacousticsTITANMay 5, 2011
K100661path medicalEARPROBEJuly 1, 2010
K092373gn otometricsICS CHARTR EP 200September 3, 2009
K090579intelligent hearing systemsSMARTSCREENER-PLUS2July 7, 2009
K083399gn otometricsICS CHARTR EP 200February 20, 2009
K082035maico diagnosticsMAICO MB 11 WITH BERAPHONE PROBEJanuary 29, 2009