FDA.reportPublic FDA data

SUNTECH MEDICAL, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10368631036863SUNTECH MEDICAL, INC.1N2026-01-015827 S. Miami Boulevard Suite 100 MORRISVILLE NC US 27560

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3921717700845K970629TANGO NON-INVASIVE BLOOD PRESSURE MONITORDXN1998-01-02
3921912494454K160439SunTech CT40 Spot-check Vital Signs DeviceDXN2016-07-06
3921581965824K151520Oscar 2DXN2016-02-19
3921670732352K122401TANGO M2 BLOOD PRESSURE MONITORDXN2012-11-02
3921338109764K080854DISPOSABLE BLOOD PRESSURE CUFF, MODEL DC100DXQ2008-10-20
3921887734005K070750247 BP DEVICEDXN2007-05-02
3921802082062K060820CYCLE BP MONITOR AND PULSE OXIMETER, MODEL 1060DXN2006-06-07
3921354598205K053209TANGO+ AUTOMATIC BLOOD PRESSURE AND OXYGEN SATURATION MEASUREMENT SYSTEMDXN2006-01-05
3921181737172K051904ALL PURPOSE CUFF, MODEL 222APCDXQ2005-09-09
3921539230165K010622PRESSURE TRAK, MODEL 222-BDXN2001-03-29
3921085643044K003004OSCAR 2, MODEL 222DXN2000-10-25
3921764933478

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DXN92016-07-06
DXQ22008-10-20

PMN#

GUDID#

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