ECG Cables And Leadwires

Cable, Transducer And Electrode, Patient, (including Connector)

Xinkang Medical Instrument Co., Ltd

The following data is part of a premarket notification filed by Xinkang Medical Instrument Co., Ltd with the FDA for Ecg Cables And Leadwires.

Pre-market Notification Details

Device IDK201359
510k NumberK201359
Device Name:ECG Cables And Leadwires
ClassificationCable, Transducer And Electrode, Patient, (including Connector)
Applicant Xinkang Medical Instrument Co., Ltd 2 Floor, Puhua Science And Technology Park, Tongsheng Community Dalang Shenzhen,  CN 518109
ContactXu Changsheng
CorrespondentField Fu
Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square Nanshan District Shenzhen,  CN 518100
Product CodeDSA  
CFR Regulation Number870.2900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-21
Decision Date2020-10-01

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