Home / Companies / Bio-Logic Systems Corp.

Bio-Logic Systems Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
45
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K122496AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEMNovember 1, 2012
K121512SCOUT SPORT OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEMJuly 26, 2012
K073626BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEMFebruary 5, 2008
K061744COCHLEA-SCAN / COCHLEA-SCAN PLUSSeptember 15, 2006
K052066CEEGRAPH/SLEEPSCAN NETLINK TRAVELERAugust 26, 2005
K031352BIO-LOGIC INSERT EARPHONESJuly 16, 2003
K030907STACKED ABR FOR NAVIGATOR PROMay 9, 2003
K031009MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL (EP) SYSTEMApril 28, 2003
K021895BIO-LOGIC MASTER EVOKED RESPONSE SYSTEMJuly 1, 2002
K021801BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONSJune 27, 2002
K021215BIO-LOGIC ABAER CUBMay 15, 2002
K012384EAR MUFFINSOctober 15, 2001
K003681BIO-LOGIC SLEEPSCAN NETLINKDecember 21, 2000
K002570BIO-LOGIC CEEGRAPH NETLINKSeptember 14, 2000
K994149MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL FOR ABAER/ NAVIGATOR PRO.December 27, 1999
K992807BIO-LOGIC EVOKED POTENTIAL FOR ABAER ISeptember 14, 1999
K983913MODIFICATION TO BIO-LOGIC SLEEPSCANNovember 25, 1998
K973883BIO-LOGIC CEEGRAPH 128-CHANNEL RECORDING SYSTEMMarch 5, 1998
K974076SPORT/AUDX OAE TEST INSTRUMENT WITH BIO-LOGIC EAR PROBEJanuary 22, 1998
K971501SLEEPSCAN AIRFLOW PRESSURE TRANSDUCEROctober 14, 1997