Disposable ECG Cable

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

Shenzhen Changke Connect Electronics Co., Ltd.

The following data is part of a premarket notification filed by Shenzhen Changke Connect Electronics Co., Ltd. with the FDA for Disposable Ecg Cable.

Pre-market Notification Details

Device IDK200026
510k NumberK200026
Device Name:Disposable ECG Cable
ClassificationCable, Transducer And Electrode, Patient, (including Connector)
Applicant Shenzhen Changke Connect Electronics Co., Ltd. A2-4th Floor Of Xiang Dali Technology Park, No.87 Of HengPing Road, Henggang, Longgang District, Shenzhen,  CN 518000
ContactYahui Zhou
CorrespondentKevin Wang
Chonconn Medical Device Consulting Co., Ltd. No. A415, Block A, NanShan Medical Devices Industrial Park Nanshan District, Shenzhen,  CN 518067
Product CodeDSA  
CFR Regulation Number870.2900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-06
Decision Date2020-05-12

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