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

    AIR PLUS AIR FLUIDIZED THERAPY SYSTEMS

    K Number: K852036 · Decision Sep 5, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    27
    Applicant Total
    1
    Review Days
    119

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    Basic Information

    Device Name
    AIR PLUS AIR FLUIDIZED THERAPY SYSTEMS
    K Number
    K852036
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5160
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Air Plus, Inc.
    Date Received
    May 9, 1985
    Decision Date
    September 5, 1985
    Product Code
    INX
    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
    INX Bed, Air Fluidized

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