U-RIGHT TD-3135 BLOOD PRESSURE MONITORING SYSTEM

System, Measurement, Blood-pressure, Non-invasive

TaiDoc Technology Corporation

The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for U-right Td-3135 Blood Pressure Monitoring System.

Pre-market Notification Details

Device IDK112274
510k NumberK112274
Device Name:U-RIGHT TD-3135 BLOOD PRESSURE MONITORING SYSTEM
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant TaiDoc Technology Corporation 3F, 5F, NO 127 WUGONG 2ND RD WUGU DISTRICT New Taipei City,  TW 24888
ContactLinda Ko
CorrespondentLinda Ko
TaiDoc Technology Corporation 3F, 5F, NO 127 WUGONG 2ND RD WUGU DISTRICT New Taipei City,  TW 24888
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-08-08
Decision Date2011-12-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00816042012242 K112274 000

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