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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K021230
Device Name HERO
Applicant
MEDICAL DECISION NETWORKS
2300 COMMONWEALTH DR.
CHARLOTTESVILLE,  VA  22901
Applicant Contact WILLIAM E KING
Correspondent
MEDICAL DECISION NETWORKS
2300 COMMONWEALTH DR.
CHARLOTTESVILLE,  VA  22901
Correspondent Contact WILLIAM E KING
Regulation Number870.2340
Classification Product Code
DPS  
Date Received04/18/2002
Decision Date 05/09/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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