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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Recorder, Magnetic Tape, Medical
510(k) Number K020825
Device Name KING OF HEARTS EXPRESS + AF MONITOR
Applicant
Card Guard Scientific Survival , Ltd.
6779 Mesa Ridge Rd.
Suite 200
San Diego,  CA  92121
Applicant Contact ALDEN KAY
Correspondent
Card Guard Scientific Survival , Ltd.
6779 Mesa Ridge Rd.
Suite 200
San Diego,  CA  92121
Correspondent Contact ALDEN KAY
Regulation Number870.2800
Classification Product Code
DSH  
Date Received03/14/2002
Decision Date 04/05/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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