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

    PARKER 500

    K Number: K110994 · Decision Jul 6, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    72
    Applicant Total
    1
    Review Days
    89

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    Basic Information

    Device Name
    PARKER 500
    K Number
    K110994
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    890.5100
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Arjohuntleigh, Inc.
    Date Received
    April 8, 2011
    Decision Date
    July 6, 2011
    Product Code
    ILJ
    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
    ILJ Bath, Hydro-Massage

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