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

    BI-3M NEEDLE-FREE INJECTOR SYSTEM

    K Number: K013256 · Decision Dec 7, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    52
    Applicant Total
    2
    Review Days
    67

    Basic Information

    Device Name
    BI-3M NEEDLE-FREE INJECTOR SYSTEM
    K Number
    K013256
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5430
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    FELTON INTERNATIONAL, INC.
    Date Received
    October 1, 2001
    Decision Date
    December 7, 2001
    Product Code
    KZE
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KZE Injector, Fluid, Non-Electrically Powered

    Similar 510(k) Clearances

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

    BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATI

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    LECTRAJET NEEDLE-FREE INJECTION SYSTEM, MODEL: M3 RA

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ZETAJET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PHARMAJET NEEDLE-FREE INJECTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    Other Clearances by FELTON INTERNATIONAL, INC.

    K Number Device Name
    K041280 HUMAN SUBCUTANEOUS INJECTOR, MODEL HSI 500