TRANSTEK BLOOD PRESSURE MONITOR

System, Measurement, Blood-pressure, Non-invasive

ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD.

The following data is part of a premarket notification filed by Zhongshan Transtek Electronics Co., Ltd. with the FDA for Transtek Blood Pressure Monitor.

Pre-market Notification Details

Device IDK123780
510k NumberK123780
Device Name:TRANSTEK BLOOD PRESSURE MONITOR
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. NO. 1 FANGHUA STREET HI-TECH DISTRICT Chengdu, Sichuan,  CN 610041
ContactLeo Wang
CorrespondentLeo Wang
ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. NO. 1 FANGHUA STREET HI-TECH DISTRICT Chengdu, Sichuan,  CN 610041
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-12-10
Decision Date2013-03-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00869876000039 K123780 000
00869876000053 K123780 000
10860005787200 K123780 000

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