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

    LASER SYS*STIM 540, MODEL ME 540

    K Number: K043586 · Decision May 6, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    462
    Registration Numbers
    462
    Same Product Code
    228
    Applicant Total
    32
    Review Days
    129

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    Basic Information

    Device Name
    LASER SYS*STIM 540, MODEL ME 540
    K Number
    K043586
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    890.5500
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mettler Electronics Corp.
    Date Received
    December 28, 2004
    Decision Date
    May 6, 2005
    Product Code
    ILY
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ILY Lamp, Infrared, Therapeutic Heating

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