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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, measurement, blood-pressure, non-invasive
510(k) Number K122401
Device Name TANGO M2 BLOOD PRESSURE MONITOR
Original Applicant
SUNTECH MEDICAL, INC.
507 airport boulevard
suite 117
morrisville,  NC  27560
Original Contact chuck setzer
Regulation Number870.1130
Classification Product Code
DXN  
Date Received08/07/2012
Decision Date 11/02/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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