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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 K131262
Device Name DIGITAL ELECTROCARDIOGRAPHS
Applicant
Sonoscape Company Limited
P.O. Box 120-119
Shanghai,  CN 237-023
Applicant Contact Diana Hong
Correspondent
Sonoscape Company Limited
P.O. Box 120-119
Shanghai,  CN 237-023
Correspondent Contact Diana Hong
Regulation Number870.2340
Classification Product Code
DPS  
Date Received05/03/2013
Decision Date 11/14/2013
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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