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510(k) Data Aggregation

    K Number
    K130439
    Device Name
    EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORING
    Manufacturer
    CHONGQING PSK SCI-TECH DEVELOPMENT CO., LTD
    Date Cleared
    2013-12-12

    (294 days)

    Product Code
    DRN
    Regulation Number
    870.5225
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHONGQING PSK SCI-TECH DEVELOPMENT CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the ECP device is to provide external counterpulsation (ECP) therapy, and is indicated for use in the treatment of stable or unstable angina pectoris, congestive heart failure, cardiogenic shock, and acute myocardial infarction.
    Device Description
    Not Found
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