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

    AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE

    K Number: K021340 · Decision Jan 30, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    33
    Applicant Total
    2
    Review Days
    279

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    Basic Information

    Device Name
    AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE
    K Number
    K021340
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5225
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    External Counterpulsation Lab
    Date Received
    April 26, 2002
    Decision Date
    January 30, 2003
    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 External Counterpulsation Lab

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