BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    WALK400H

    K Number: K091054 · Decision Jul 27, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    48
    Registration Numbers
    48
    Same Product Code
    59
    Applicant Total
    3
    Review Days
    105

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    Basic Information

    Device Name
    WALK400H
    K Number
    K091054
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    870.2800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Et Medical Devices Spa
    Date Received
    April 13, 2009
    Decision Date
    July 27, 2009
    Product Code
    MWJ
    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
    MWJ Electrocardiograph, Ambulatory (Without Analysis)

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