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

    ECG Cables and Leadwires

    K Number: K201359 · Decision Oct 1, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    139
    Registration Numbers
    139
    Same Product Code
    104
    Applicant Total
    2
    Review Days
    133

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    Basic Information

    Device Name
    ECG Cables and Leadwires
    K Number
    K201359
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2900
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Xinkang Medical Instrument Co. , Ltd.
    Date Received
    May 21, 2020
    Decision Date
    October 1, 2020
    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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