Medical Device Manufacturer · US , Mchenry , IL

Bio-Logic Systems Corp. - FDA 510(k) Cleared Devices

45 submissions · 45 cleared · Since 1981

45

Total

45

Cleared

0

Denied

FDA 510(k) Regulatory Record - Bio-Logic Systems Corp. Ear, Nose, Throat ✕

10 devices

1-10 of 10

Cleared Nov 01, 2012

AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM

Ear, Nose, Throat · 77d

Cleared Jul 26, 2012

SCOUT SPORT OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM

Ear, Nose, Throat · 66d

Cleared Sep 15, 2006

COCHLEA-SCAN / COCHLEA-SCAN PLUS

Ear, Nose, Throat · 86d

Cleared Jul 16, 2003

BIO-LOGIC INSERT EARPHONES

Ear, Nose, Throat · 78d

Cleared Jun 27, 2002

BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS

Ear, Nose, Throat · 24d

Cleared Jan 22, 1998

SPORT/AUDX OAE TEST INSTRUMENT WITH BIO-LOGIC EAR PROBE

Ear, Nose, Throat · 85d

Cleared May 13, 1997

MODIFICATION TO OTOACOUSTIC EMISSIONS (OAE0 TEST INSTRUMENT

Ear, Nose, Throat · 210d

Cleared May 29, 1996

SCOUT SPORT - A MODIFICATION TO (FORMERLY EMAV) OTOACOUSTIC EMISSIONS (OAE)...

Ear, Nose, Throat · 43d

Cleared Dec 21, 1994

BIO-LOGIC EMAV EMISSION AVERAGING OTOACOUSTIC TEST

Ear, Nose, Throat · 86d

Cleared Apr 16, 1987

Ear, Nose, Throat · 78d