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

    NEUTROLUMENPN SYSTEM, MODEL 1000

    K Number: K082223 · Decision Apr 21, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    462
    Registration Numbers
    462
    Same Product Code
    228
    Applicant Total
    2
    Review Days
    258

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    Basic Information

    Device Name
    NEUTROLUMENPN SYSTEM, MODEL 1000
    K Number
    K082223
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5500
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Neurolumen, LLC
    Date Received
    August 6, 2008
    Decision Date
    April 21, 2009
    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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    Other Clearances by Neurolumen, LLC

    K Number Device Name
    K142025 NEUROLUMEN PN-1000