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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 K983533
Device Name ACTIWATCH
Applicant
Mini-Mitter Co., Inc.
P.O. Box 3386
Sunriver,  OR  97707
Applicant Contact JACK E MCKENZIE
Correspondent
Mini-Mitter Co., Inc.
P.O. Box 3386
Sunriver,  OR  97707
Correspondent Contact JACK E MCKENZIE
Regulation Number882.1400
Classification Product Code
GWQ  
Date Received10/08/1998
Decision Date 03/23/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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