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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 K180242
Device Name HeRO Symphony, HeRO ES, HeRO solo/duet
Applicant
Medical Predictive Science Corporation
2246 Ivy Rd Suite 17
Charlottesville,  VA  22903
Applicant Contact Will King
Correspondent
Medical Predictive Science Corporation
2246 Ivy Rd Suite 17
Charlottesville,  VA  22903
Correspondent Contact Will King
Regulation Number870.2340
Classification Product Code
DPS  
Date Received01/29/2018
Decision Date 02/28/2018
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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