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

    IMMERSION HYDROBATH

    K Number: K082951 · Decision Apr 8, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    72
    Applicant Total
    1
    Review Days
    187

    Basic Information

    Device Name
    IMMERSION HYDROBATH
    K Number
    K082951
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5100
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    ARJO HOSPITAL EQUIPMENT AB
    Date Received
    October 3, 2008
    Decision Date
    April 8, 2009
    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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