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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
Original Applicant
CELLO PARTNERSHIP D/B/A VERIZON WIRELESS
1300 i st nw, suite 400 w
washington,  DC  20005
Original 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
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