TRANSTEK 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 Transtek Blood Pressure Monitor.

Pre-market Notification Details

Device IDK131395
510k NumberK131395
Device Name:TRANSTEK BLOOD PRESSURE MONITOR
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD NO.1 FANGHUA STREET, HI-TECH DISTRICT Chengdu, Sichuan,  CN 610041
ContactLeo Wang
CorrespondentLeo Wang
GUANGDONG TRANSTEK MEDICAL 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 Received2013-05-15
Decision Date2013-06-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00075020056382 K131395 000
10875011006047 K131395 000
10858069007044 K131395 000
04719878120012 K131395 000
34719878120020 K131395 000
30860002249699 K131395 000
10875011006344 K131395 000
10810038632565 K131395 000
10875011000403 K131395 000

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