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

    CLINITRON RITE-HITE

    K Number: K964223 · Decision May 28, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    27
    Applicant Total
    33
    Review Days
    217

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    Basic Information

    Device Name
    CLINITRON RITE-HITE
    K Number
    K964223
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5160
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hill-Rom, Inc.
    Date Received
    October 23, 1996
    Decision Date
    May 28, 1997
    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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