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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Detector And Alarm, Arrhythmia
510(k) Number K142180
Device Name TELESENSE
Applicant
Scottcare Corporation
4791 W. 150th St.
Cleveland,  OH  44135
Applicant Contact SNEHRAJ MERCHANT
Correspondent
Scottcare Corporation
4791 W. 150th St.
Cleveland,  OH  44135
Correspondent Contact SNEHRAJ MERCHANT
Regulation Number870.1025
Classification Product Code
DSI  
Subsequent Product Code
DRG  
Date Received08/08/2014
Decision Date 12/12/2014
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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