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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Encephalogram Telemetry System
510(k) Number K832304
Device Name BRAEGEN III 10-CHANNEL TRANSMITTER-
Applicant
ELECTRO-BIO-MEDICAL SERVICES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
ELECTRO-BIO-MEDICAL SERVICES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number882.1855
Classification Product Code
GYE  
Date Received07/14/1983
Decision Date 08/31/1983
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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