Medical Device Manufacturer · US , North Miami , FL

Intelligent Hearing Systems - FDA 510(k) Cleared Devices

13 submissions · 13 cleared · Since 1991

Total

Cleared

Denied

Intelligent Hearing Systems has 13 FDA 510(k) cleared neurology devices. Based in North Miami, US.

Historical record: 13 cleared submissions from 1991 to 2017.

Browse the complete list of FDA 510(k) cleared neurology devices from this manufacturer. Filter by specialty or product code using the sidebar.

Intelligent Hearing Systems is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Intelligent Hearing Systems

13 devices

1-12 of 13

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

SMARTEP-ASSR, MODEL M811007

Ear, Nose, Throat · 49d

Cleared Feb 03, 1997

SMARTOAE

K964426 · EWO

Ear, Nose, Throat · 90d

Cleared May 11, 1993

SMART-SCREENER (AUDITORY)

Intelligent Hearing Systems - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Intelligent Hearing Systems

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