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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K142349
Device Name TM eCloud ECG Analysis System
Applicant
Telemed Solutions, Inc.
6251 Schaefer Ave., Suite K
Chino,  CA  91710
Applicant Contact Ken Burns
Correspondent
Telemed Solutions, Inc.
6251 Schaefer Ave., Suite K
Chino,  CA  91710
Correspondent Contact Ken Burns
Regulation Number870.1425
Classification Product Code
DQK  
Date Received08/22/2014
Decision Date 09/21/2015
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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