TRANSTEK BLOOD PRESSURE MONITOR MODEL TMB-986, TMB-987, TMB-995

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 Model Tmb-986, Tmb-987, Tmb-995.

Pre-market Notification Details

Device IDK101681
510k NumberK101681
Device Name:TRANSTEK BLOOD PRESSURE MONITOR MODEL TMB-986, TMB-987, TMB-995
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)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-06-15
Decision Date2011-05-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00817746020007 K101681 000
00850253007185 K101681 000

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