Product code GWJ— Neurology
EARPROBE
- Classification name
- Stimulator, Auditory, Evoked Response
- Device class
- Class 2
- Regulation
- 21 CFR 882.1900
- Advisory panel
- Neurology
- Total cleared
- 76
- First cleared
- Most recent
Market context for product code GWJ
FDA has cleared devices under product code GWJ between 1977 and 2024, filed by 40 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2024
- 2022
- 2021
- 2020
- 2017
- 2015
- 2014
- 2013
- 2012
- 2011
- 2010
- 2009
- 2008
- 2007
- 2006
Top applicants under product code GWJ
Recent clearances under product code GWJ
- K242954 — Integrity V500 (Integrity, Integrity with VEMP)
- K233649 — ALGO Pro Newborn Hearing Screener (ALGO Pro)
- K220139 — QScreen
- K211147 — ALGO 7i
- K193033 — GSI Audera Pro
- K163326 — SmartEP
- K162037 — Eclipse with VEMP
- K143670 — ICS CHARTR EP 200 WITH VEMP
- K141446 — ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO HEARING SCREENER WITHOUT BARCODE SCANNER,
- K132957 — MADSEN ACCUSCREEN TYPE 1077
- K131141 — EARPROBE
- K123701 — HEARLAB ACA
- K122067 — TYPE 1077 ACCUSCREEN
- K111555 — CIRCUMAURAL ADHESIVE REPLACEMENT
- K103760 — TITAN
- K100661 — EARPROBE
- K092373 — ICS CHARTR EP 200
- K090579 — SMARTSCREENER-PLUS2
- K083399 — ICS CHARTR EP 200
- K082035 — MAICO MB 11 WITH BERAPHONE PROBE
- K080060 — VIVOSONIC NEUROSCREEN
- K073384 — SMART COUPLER, MODEL M015401
- K073626 — BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEM
- K073665 — ALGO 5 NEWBORN HEARING SCREENER
- K070608 — SMARTEP, MODEL M010000
- K070696 — INTERACOUSTICS ASSR, ECLIPSE SYSTEM (CABINET NAME)
- K061443 — SMART USBLITE, MODEL M011120
- K043396 — INTEGRITY, MODEL V500
- K031051 — SMARTEP-ASSR, MODEL M811007
- K030907 — STACKED ABR FOR NAVIGATOR PRO
- K031009 — MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL (EP) SYSTEM
- K030823 — ALGO 3I NEWBORN HEARING SCREENER
- K021895 — BIO-LOGIC MASTER EVOKED RESPONSE SYSTEM
- K013977 — ECHO-SCREEN T, TA, TD, TDA, TC
- K021215 — BIO-LOGIC ABAER CUB
- K011842 — SABRE COMPAC
- K012415 — AURIS AEP
- K013137 — ALGO 3 NEWBORN HEARING SCREENER
- K011746 — MB 11
- K002985 — ICS MEDICAL CHARTR EP AND CHARTR OAE SYSTEMS
- K994149 — MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL FOR ABAER/ NAVIGATOR PRO.
- K993177 — SABRE
- K991853 — INTERACOUSTICS EP 15 ABR STAND ALONE UNIT
- K992807 — BIO-LOGIC EVOKED POTENTIAL FOR ABAER I
- K972157 — EXCEL AV STIM 1000
- K960097 — CHARTR EP
- K953732 — TECA PREMIERE
- K952080 — CLARITY SYSTEM II
- K936039 — ALGO-2 NEWBORN HEARING SCREENER
- K925648 — SMART-SCREENER (AUDITORY)
- K926574 — MODEL 330 SCREENING AUDIO METER, MODIFIED
- K913957 — DANTEC COUNTERPOINT MK2(TM)
- K913785 — CORONET 100
- K904926 — SMART-EP
- K905632 — NICOLET MAPLELEAF SYSTEM
- K874193 — MICROSHEV MODEL 2000
- K870030 — THE SCREENER GSI 55 ABR SCREENER
- K862906 — TECA/MEDELEC AS-10 SENSOR
- K863156 — TECA/MEDELEC AUDIOSTAR
- K863985 — EVOPORT 100
- K862430 — SIEGEN HEADPHONES
- K862361 — 40-HZ AUDITORY EVOKED RESPONSE TEST
- K862363 — INSERT EARPHONES
- K852687 — ALGO I
- K832510 — EVOKED POTENTIALS SYSTEM MK10
- K830579 — MULTI-SIGNAL AUDITORY STIMULATOR SM700
- K822177 — AUDIOMETERS (VARIOUS MODELS)
- K813009 — TECA VISUAL/AUDIO STIMULATOR MODEL CS-2
- K810473 — MK6 ERA SYSTEM
- K810138 — SYNAP-I INFANT SENSORY ASSESSMENT UNIT
- K810539 — MODEL S10CTCM AUDITORY STIMULATOR
- K792085 — C-ERA-100 COMPUTERIZED ELECTRIC RESPON
- K781667 — AMPLAID MARK 4 AND MARK 5
- K780540 — ELECTRIC RESPONSE AUDIOMETER
- K770878 — SIGNAL PROCESSOR/AVERAGER MODEL 7S11
- K770268 — SYS. FOR REC. BSER RESPONSES
Data sourced from openFDA. This site is unofficial and independent of the FDA.