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

    TERRAN BIOMECHANICAL ANALYSIS SYSTEM

    K Number: K851133 · Decision Jun 19, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    7
    Applicant Total
    1
    Review Days
    90

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    Basic Information

    Device Name
    TERRAN BIOMECHANICAL ANALYSIS SYSTEM
    K Number
    K851133
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Terran Biomedical Instruments
    Date Received
    March 21, 1985
    Decision Date
    June 19, 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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