BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SIM 4000I

    K Number: K873845 · Decision Apr 7, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    348
    Registration Numbers
    349
    Same Product Code
    892
    Applicant Total
    2
    Review Days
    198

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    Basic Information

    Device Name
    SIM 4000I
    K Number
    K873845
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1560
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Ote-Biomedica Elettronica S.P.A
    Date Received
    September 22, 1987
    Decision Date
    April 7, 1988
    Product Code
    IYO
    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
    IYO System, Imaging, Pulsed Echo, Ultrasonic

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    Other Clearances by Ote-Biomedica Elettronica S.P.A

    K Number Device Name
    K874548 SIM 4000C