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

    EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORING

    K Number: K130439 · Decision Dec 12, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    33
    Applicant Total
    1
    Review Days
    294

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    Basic Information

    Device Name
    EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORING
    K Number
    K130439
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5225
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Chongqing Psk Sci-Tech Development Co., Ltd.
    Date Received
    February 21, 2013
    Decision Date
    December 12, 2013
    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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