The following data is part of a premarket notification filed by Shenzhen Changke Connect Electronics Co., Ltd. with the FDA for Disposable Ecg Cable.
|Device Name:||Disposable ECG Cable|
|Classification||Cable, 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|
Chonconn Medical Device Consulting Co., Ltd. No. A415, Block A, NanShan Medical Devices Industrial Park Nanshan District, Shenzhen, CN 518067
|CFR Regulation Number||870.2900 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|