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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transmitters And Receivers, Electrocardiograph, Telephone
510(k) Number K896039
Device Name KING OF HEARTS 1200 MONITOR
Applicant
Instromedix, Inc.
One Technology Center
7431 NE Evergreen Pkwy.
Hillsboro,  OR  97124
Applicant Contact SEMLER, M.D.
Correspondent
Instromedix, Inc.
One Technology Center
7431 NE Evergreen Pkwy.
Hillsboro,  OR  97124
Correspondent Contact SEMLER, M.D.
Regulation Number870.2920
Classification Product Code
DXH  
Date Received10/16/1989
Decision Date 02/28/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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