BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MODIFICATION TO HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS

    K Number: K013564 · Decision Nov 21, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    574
    Applicant Total
    17
    Review Days
    26

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    Basic Information

    Device Name
    MODIFICATION TO HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS
    K Number
    K013564
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.2340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cambridge Heart, Inc.
    Date Received
    October 26, 2001
    Decision Date
    November 21, 2001
    Product Code
    DPS
    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
    DPS Electrocardiograph

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