CONTEC ELECTROCARDIOGRAPH

Electrocardiograph

CONTEC MEDICAL SYSTEM CO., LTD.

The following data is part of a premarket notification filed by Contec Medical System Co., Ltd. with the FDA for Contec Electrocardiograph.

Pre-market Notification Details

Device IDK131900
510k NumberK131900
Device Name:CONTEC ELECTROCARDIOGRAPH
ClassificationElectrocardiograph
Applicant CONTEC MEDICAL SYSTEM CO., LTD. P.O. BOX 120-119 Shanghai,  CN 200120
ContactDiana Hong
CorrespondentDiana Hong
CONTEC MEDICAL SYSTEM 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 Received2013-06-25
Decision Date2014-03-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06945040100492 K131900 000
06945040100089 K131900 000
06945040100072 K131900 000
06945040105756 K131900 000

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