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

    SYRINGE, CO2 DRIVEN, IL AUTOMATIC INJECT

    K Number: K760448 · Decision Aug 27, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    2
    Applicant Total
    321
    Review Days
    11

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    Basic Information

    Device Name
    SYRINGE, CO2 DRIVEN, IL AUTOMATIC INJECT
    K Number
    K760448
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1660
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Instrumentation Laboratory CO
    Date Received
    August 16, 1976
    Decision Date
    August 27, 1976
    Product Code
    DXL
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DXL Injector, Indicator

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