TANGO M2 BLOOD PRESSURE MONITOR

System, Measurement, Blood-pressure, Non-invasive

SUNTECH MEDICAL, INC.

The following data is part of a premarket notification filed by Suntech Medical, Inc. with the FDA for Tango M2 Blood Pressure Monitor.

Pre-market Notification Details

Device IDK122401
510k NumberK122401
Device Name:TANGO M2 BLOOD PRESSURE MONITOR
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant SUNTECH MEDICAL, INC. 507 AIRPORT BOULEVARD SUITE 117 Morrisville,  NC  27560
ContactChuck Setzer
CorrespondentChuck Setzer
SUNTECH MEDICAL, INC. 507 AIRPORT BOULEVARD SUITE 117 Morrisville,  NC  27560
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-08-07
Decision Date2012-11-02
Summary:summary

NIH GUDID Devices

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