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

    External Counterpulsation System, Soulaire

    K Number: K202108 · Decision Aug 28, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    33
    Applicant Total
    2
    Review Days
    29

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    Basic Information

    Device Name
    External Counterpulsation System, Soulaire
    K Number
    K202108
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.5225
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vamed Medical Instrument Co., Ltd.
    Date Received
    July 30, 2020
    Decision Date
    August 28, 2020
    Product Code
    DRN
    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
    DRN Device, Counter-Pulsating, External

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    Other Clearances by Vamed Medical Instrument Co., Ltd.

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    K190683 External Counterpulsation System