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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transmitters And Receivers, Physiological Signal, Radiofrequency
510(k) Number K122458
Device Name VERIZON WIRELESS REMOTE HEALTH MANAGEMENT SYSTEM
Applicant
Cello Partnership D/B/A Verizon Wireless
1300 I St. NW, Suite 400 W
Washington,  DC  20005
Applicant Contact LOLITA FORBES
Correspondent
Cello Partnership D/B/A Verizon Wireless
1300 I St. NW, Suite 400 W
Washington,  DC  20005
Correspondent Contact LOLITA FORBES
Regulation Number870.2910
Classification Product Code
DRG  
Date Received08/13/2012
Decision Date 07/30/2013
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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