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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electromyograph, Diagnostic
510(k) Number K930328
Device Name NAVIGATOR & TRAVELER EVOKED POSTENTIAL PRODUCT
Applicant
Bio-Logic Systems Corp.
One Bio-Logic Plaza
Mundelein,  IL  60060 -3700
Applicant Contact CATHY BUHNER
Correspondent
Bio-Logic Systems Corp.
One Bio-Logic Plaza
Mundelein,  IL  60060 -3700
Correspondent Contact CATHY BUHNER
Regulation Number890.1375
Classification Product Code
IKN  
Date Received01/22/1993
Decision Date 07/02/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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