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

    DIGITAL BALLISTOCARDIOGRAPH, MODEL DGB 300

    K Number: K081603 · Decision Jul 24, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    4
    Applicant Total
    1
    Review Days
    413

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    Basic Information

    Device Name
    DIGITAL BALLISTOCARDIOGRAPH, MODEL DGB 300
    K Number
    K081603
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2320
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Heartforce Medical, Inc.
    Date Received
    June 6, 2008
    Decision Date
    July 24, 2009
    Product Code
    DXR
    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
    DXR Ballistocardiograph

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