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

    KEANE MOBILITY BED

    K Number: K873047 · Decision Oct 15, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    16
    Applicant Total
    5
    Review Days
    72

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    Basic Information

    Device Name
    KEANE MOBILITY BED
    K Number
    K873047
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5225
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Surgi-Med, Inc.
    Date Received
    August 4, 1987
    Decision Date
    October 15, 1987
    Product Code
    IKZ
    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
    IKZ Bed, Patient Rotation, Powered

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    Other Clearances by Surgi-Med, Inc.

    K Number Device Name
    K881705 MODEL 5000 AIR-FLUIDIZED SUPPORT SYSTEM
    K872923 PARAGON 9000 TILT AND TURN BED
    K872924 PARAGON 8500 CARDIO-PULMONARY BED
    K872925 MEGABED 1000