BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    CAMBRIDGE MODEL XT1000

    K Number: K854283 · Decision Nov 13, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    42
    Applicant Total
    8
    Review Days
    20

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    Basic Information

    Device Name
    CAMBRIDGE MODEL XT1000
    K Number
    K854283
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5380
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Cambridge Medical Instruments, Inc.
    Date Received
    October 24, 1985
    Decision Date
    November 13, 1985
    Product Code
    IOL
    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
    IOL Treadmill, Powered

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