BIO-LOGIC ABAER CUB


Device Classification Name

stimulator, auditory, evoked response

510(k) Number K021215
Device Name BIO-LOGIC ABAER CUB
Original Applicant
BIO-LOGIC SYSTEMS CORP.
one bio-logic plaza
mundelein, 
IL 
60060 -3700

Original Contact norman e brunner
Regulation Number 882.1900
Classification Product Code
GWJ  
Date Received 04/17/2002
Decision Date 05/15/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No