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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stimulator, photic, evoked response
510(k) Number K831047
Device Name BIOLOGIC SYSTEM BL 101
Original Applicant
BIO-LOGIC SYSTEMS CORP.
Regulation Number882.1890
Classification Product Code
GWE  
Date Received03/31/1983
Decision Date 05/13/1983
Decision substantially equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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