BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE

    K Number: K012141 · Decision Oct 25, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    33
    Applicant Total
    2
    Review Days
    107

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    Basic Information

    Device Name
    AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE
    K Number
    K012141
    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
    July 10, 2001
    Decision Date
    October 25, 2001
    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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    K021340 AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE