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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electrical, Evoked Response
510(k) Number K844992
Device Name BIO-LOGIC PORTABLE EVOKED RESPONSE SYSTEM
Applicant
Bio-Logic Systems Corp.
425 Huehl Rd.
Northbrook,  IL  60062
Applicant Contact GABRIEL RAVIV
Correspondent
Bio-Logic Systems Corp.
425 Huehl Rd.
Northbrook,  IL  60062
Correspondent Contact GABRIEL RAVIV
Regulation Number882.1870
Classification Product Code
GWF  
Date Received12/26/1984
Decision Date 06/07/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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