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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.
PO BOX 3386
SUNRIVER,  OR  97707
Applicant Contact JACK E MCKENZIE
Correspondent
MINI-MITTER CO., INC.
PO 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
Recalls CDRH Recalls
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