Medical Device Manufacturer · US , North Miami , FL

Intelligent Hearing Systems

13 submissions · 13 cleared · Since 1991
13
Total
13
Cleared
0
Denied

Intelligent Hearing Systems — FDA 510(k) Submissions

Intelligent Hearing Systems has submitted 13 FDA 510(k) premarket notifications since 1991, of which 13 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Stimulator, Auditory, Evoked Response, Audiometer, Amplifier, Physiological Signal, Electrode, Cutaneous . Use the specialty filter in the sidebar to narrow results.

13 devices
1–13 of 13
SmartEP
K163326 · GWJ Stimulator, Auditory,... · Neurology
Sep 2017 305d
SMARTSCREENER-PLUS2
K090579 · GWJ Stimulator, Auditory,... · Neurology
Jul 2009 126d
SMART COUPLER, MODEL M015401
K073384 · GWJ Stimulator, Auditory,... · Neurology
Feb 2008 87d
SMARTEP, MODEL M010000
K070608 · GWJ Stimulator, Auditory,... · Neurology
Jul 2007 135d
WICK ELECTRODE, MODEL M019260
K063402 · GXY Electrode, Cutaneous · Neurology
Dec 2006 32d
SMART USBLITE, MODEL M011120
K061443 · GWJ Stimulator, Auditory,... · Neurology
Jun 2006 30d
OPTI-AMP DC-POWERED
K052060 · GWL Amplifier, Physiological... · Neurology
Aug 2005 33d
SMARTEP-ASSR, MODEL M811007
K031051 · GWJ Stimulator, Auditory,... · Neurology
Feb 2004 324d
SMARTTROAE
K023859 · EWO Audiometer · Ear, Nose, Throat
Jan 2003 49d
SMARTOAE
K964426 · EWO Audiometer · Ear, Nose, Throat
Feb 1997 90d
SMART-SCREENER (AUDITORY)
K925648 · GWJ Stimulator, Auditory,... · Neurology
May 1993 183d
OPTI-AMP
K914876 · GWL Amplifier, Physiological... · Neurology
Jan 1992 73d
SMART-EP
K904926 · GWJ Stimulator, Auditory,... · Neurology
Aug 1991 275d
Filters