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

    RUMORS DYNAMIC AIR THERAPY UNIT

    K Number: K972111 · Decision Feb 2, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    16
    Applicant Total
    33
    Review Days
    242

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    Basic Information

    Device Name
    RUMORS DYNAMIC AIR THERAPY UNIT
    K Number
    K972111
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5225
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hill-Rom, Inc.
    Date Received
    June 5, 1997
    Decision Date
    February 2, 1998
    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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