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

    MODEL 5000 AIR-FLUIDIZED SUPPORT SYSTEM

    K Number: K881705 · Decision Jul 13, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    27
    Applicant Total
    5
    Review Days
    85

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    Basic Information

    Device Name
    MODEL 5000 AIR-FLUIDIZED SUPPORT SYSTEM
    K Number
    K881705
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5160
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Surgi-Med, Inc.
    Date Received
    April 19, 1988
    Decision Date
    July 13, 1988
    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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