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

    MEDI-JECTOR CHOICE NEEDLE-FREE INSULIN DELIVERY SYSTEM

    K Number: K962956 · Decision Oct 7, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    52
    Applicant Total
    3
    Review Days
    69

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    Basic Information

    Device Name
    MEDI-JECTOR CHOICE NEEDLE-FREE INSULIN DELIVERY SYSTEM
    K Number
    K962956
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5430
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medi-Ject Corp.
    Date Received
    July 30, 1996
    Decision Date
    October 7, 1996
    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

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    Other Clearances by Medi-Ject Corp.

    K Number Device Name
    K991294 MODIFICATION TO MEDI-JECT CORPORATION MEDI-JECTOR CHOICE NEEDLE-FREE INSULIN DELIVERY SYSTEM
    K960285 MEDI-JECT CORPORATION MEDI-JECTOR NEEDLE-FREE BIO-TROPIN DDRUG DELIVERY SYSTEMS 0.0058/0.0068(INCH DIAMETER NOZZLEORIFIC