Blood Pressure Monitor

System, Measurement, Blood-pressure, Non-invasive

Guangdong Transtek Medical Electronics Co., Ltd.

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

Pre-market Notification Details

Device IDK202891
510k NumberK202891
Device Name:Blood Pressure Monitor
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant Guangdong Transtek Medical Electronics Co., Ltd. Zone B, No.105, Dongli Road, Torch Development District, Zhongshan,  CN 528437
ContactEndless Chan
CorrespondentKevin Wang
Chonconn Medical Device Consulting Co., Ltd. Room 508, Block C, No. 1029 Nanhai Avenue, Nanshan District Shenzhen,  CN 518067
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-28
Decision Date2021-03-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10860004709531 K202891 000
20860004709507 K202891 000
00860004709596 K202891 000

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