BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    ECG Cable

    K Number: K191428 · Decision Nov 27, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    139
    Registration Numbers
    139
    Same Product Code
    104
    Applicant Total
    8
    Review Days
    182

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    Basic Information

    Device Name
    ECG Cable
    K Number
    K191428
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2900
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Changke Connect Electronics Co., Ltd.
    Date Received
    May 29, 2019
    Decision Date
    November 27, 2019
    Product Code
    DSA
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DSA Cable, Transducer And Electrode, Patient, (Including Connector)

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    Other Clearances by Shenzhen Changke Connect Electronics Co., Ltd.

    K Number Device Name
    K213884 Disposable EEG cable
    K193625 Disposable Temperature Probe
    K200026 Disposable ECG Cable
    K193629 Disposable NIBP Cuff
    K200069 Disposable SpO2 Sensor
    K191420 Reusable SpO2 Sensor
    K191253 Reusable NIBP Cuff