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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Full-Montage Standard Electroencephalograph
510(k) Number K841684
Device Name BIO/SCAN BIOLOG CASSETTE RECORDER
Applicant
Bio-Scan, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Bio-Scan, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number882.1400
Classification Product Code
GWQ  
Date Received04/23/1984
Decision Date 06/07/1984
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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