BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS


Device Classification Name

audiometer

510(k) Number K021801
Device Name BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS
Original Applicant
BIO-LOGIC SYSTEMS CORP.
one bio-logic plaza
mundelein, 
IL 
60060 -3700

Original Contact norman e brunner
Regulation Number 874.1050
Classification Product Code
EWO  
Subsequent Product Code
GWJ  
Date Received 06/03/2002
Decision Date 06/27/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ear Nose & Throat

510k Review Panel

Ear Nose & Throat

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No