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

    D-SCOPE II AND D-SCOPE IIC

    K Number: K872127 · Decision Jun 18, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    129
    Applicant Total
    8
    Review Days
    16

    Basic Information

    Device Name
    D-SCOPE II AND D-SCOPE IIC
    K Number
    K872127
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1100
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    MEDX, INC.
    Date Received
    June 2, 1987
    Decision Date
    June 18, 1987
    Product Code
    IYX
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IYX Camera, Scintillation (Gamma)

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