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

    DERATA MEDI-JECTOR V

    K Number: K883847 · Decision Oct 31, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    52
    Applicant Total
    6
    Review Days
    49

    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
    DERATA MEDI-JECTOR V
    K Number
    K883847
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5430
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Derata Corp.
    Date Received
    September 12, 1988
    Decision Date
    October 31, 1988
    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 Derata Corp.

    K Number Device Name
    K864561 DERATA MEDI-JECTOR IV
    K844244 DERATA MEDI-JECTOR PRO
    K844111 DERATA MEDI-JECTOR III
    K834044 MEDI-JECTOR II
    K772129 MEDI-JECTOR