Portable ECG Monitor

Electrocardiograph

CONTEC Medical Systems Co.,Ltd

The following data is part of a premarket notification filed by Contec Medical Systems Co.,ltd with the FDA for Portable Ecg Monitor.

Pre-market Notification Details

Device IDK170954
510k NumberK170954
Device Name:Portable ECG Monitor
ClassificationElectrocardiograph
Applicant CONTEC Medical Systems Co.,Ltd No.112 Qinhuang West Street, Economic& Technical Development Qinhuangdao,  CN 066004
ContactXueyong Li
CorrespondentDiana Hong
Mid-Link Consulting Co.,Ltd P.O. Box 120-119 Shanghai,  CN 200120
Product CodeDPS  
CFR Regulation Number870.2340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-03-31
Decision Date2017-05-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06945040104421 K170954 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.