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

    ISIS

    K Number: K844736 · Decision Mar 21, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    7
    Applicant Total
    48
    Review Days
    106

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    Basic Information

    Device Name
    ISIS
    K Number
    K844736
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Oxford Medilog, Inc.
    Date Received
    December 5, 1984
    Decision Date
    March 21, 1985
    Product Code
    LDK
    Advisory Committee
    Unknown
    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
    LDK Device, Sensing, Optical Contour

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