BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇮🇱 Israel

    ORTELIUS 800

    K Number: K011827 · Decision Aug 28, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    32
    Applicant Total
    1
    Review Days
    77

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    Basic Information

    Device Name
    ORTELIUS 800
    K Number
    K011827
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    888.1500
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Orthoscan , Ltd.
    Date Received
    June 12, 2001
    Decision Date
    August 28, 2001
    Product Code
    KQX
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KQX Goniometer, Ac-Powered

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