Intelligent Hearing Systems - FDA 510(k) Cleared Devices

Cleared Sep 29, 2017

SmartEP

K163326 · GWJ

Neurology · 305d

Cleared Jul 07, 2009

SMARTSCREENER-PLUS2

K090579 · GWJ

Neurology · 126d

Cleared Feb 28, 2008

SMART COUPLER, MODEL M015401

K073384 · GWJ

Neurology · 87d

Cleared Jul 18, 2007

SMARTEP, MODEL M010000

K070608 · GWJ

Neurology · 135d

Cleared Dec 11, 2006

WICK ELECTRODE, MODEL M019260

K063402 · GXY

Neurology · 32d

Cleared Jun 23, 2006

SMART USBLITE, MODEL M011120

K061443 · GWJ

Neurology · 30d

Cleared Aug 31, 2005

OPTI-AMP DC-POWERED

K052060 · GWL

Neurology · 33d

Cleared Feb 20, 2004

SMARTEP-ASSR, MODEL M811007

K031051 · GWJ

Neurology · 324d

Cleared May 11, 1993

SMART-SCREENER (AUDITORY)

K925648 · GWJ

Neurology · 183d

Cleared Jan 10, 1992

OPTI-AMP

K914876 · GWL

Neurology · 73d

Cleared Aug 02, 1991

SMART-EP

K904926 · GWJ

Neurology · 275d