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

    DUFFY BOLUS INJECTOR

    K Number: K863936 · Decision Jan 6, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    3
    Applicant Total
    2
    Review Days
    89

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    DUFFY BOLUS INJECTOR
    K Number
    K863936
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.6500
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Viox Corp.
    Date Received
    October 9, 1986
    Decision Date
    January 6, 1987
    Product Code
    IWR
    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
    IWR Holder, Syringe, Lead

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (IWR), ordered by most recent decision date.

    ALL-VUE ULTRA-LITE THIN WALL SYRINGE SHIELD

    FDA 510(k)
    FDA Class 1 ·Radiology

    LEAD GLASS SHIELDS

    FDA 510(k)
    FDA Class 1 ·Radiology

    TUNGSTEN SYRINGE SHIELD

    FDA 510(k)
    FDA Class 1 ·Radiology
    View all

    Other Clearances by Viox Corp.

    K Number Device Name
    K872656 LEAD GLASS SHIELDS