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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 K111601
Device Name HERO
Applicant
MEDICAL PREDICTIVE SCIENCE CORP.
2246 IVY RD., SUITE 17
CHARLOTTESVILLE,  VA  22903
Applicant Contact WILL KING
Correspondent
MEDICAL PREDICTIVE SCIENCE CORP.
2246 IVY RD., SUITE 17
CHARLOTTESVILLE,  VA  22903
Correspondent Contact WILL KING
Regulation Number870.2340
Classification Product Code
DPS  
Date Received06/08/2011
Decision Date 07/08/2011
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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