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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 K883461
Device Name DAD 16S, DATA ACQUISTION DEVICE 16 CH. SERIES
Applicant
Biohm, Inc.
1050 Walnut St. Suite 205
Boulder,  CO  80302
Applicant Contact MILLER, MD
Correspondent
Biohm, Inc.
1050 Walnut St. Suite 205
Boulder,  CO  80302
Correspondent Contact MILLER, MD
Regulation Number882.1855
Classification Product Code
GYE  
Date Received08/12/1988
Decision Date 11/30/1988
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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