BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEM


Device Classification Name

stimulator, auditory, evoked response

510(k) Number K073626
Device Name BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEM
Applicant
BIO-LOGIC SYSTEMS CORP.
one biologic plaza
mundelein, 
IL 
60060

Applicant Contact nicohl wilding
Correspondent
BIO-LOGIC SYSTEMS CORP.
one biologic plaza
mundelein, 
IL 
60060

Correspodent Contact nicohl wilding
Regulation Number 882.1900
Classification Product Code
GWJ  
Date Received 12/26/2007
Decision Date 02/05/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No