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

    EUREKA EXTENSION CYLINDERS

    K Number: K904489 · Decision Oct 15, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    15
    Applicant Total
    2
    Review Days
    13

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    Basic Information

    Device Name
    EUREKA EXTENSION CYLINDERS
    K Number
    K904489
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1610
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Eureka X-Ray Tube Corp.
    Date Received
    October 2, 1990
    Decision Date
    October 15, 1990
    Product Code
    KPW
    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
    KPW Device, Beam Limiting, X-Ray, Diagnostic

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    Other Clearances by Eureka X-Ray Tube Corp.

    K Number Device Name
    K760604 EUREKA X-SCAN 150 X-RAY TUBE HOUSING AS.