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

    INSPIRON LIQUID OXYGEN SYSTEM

    K Number: K834290 · Decision Feb 4, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    54
    Applicant Total
    20
    Review Days
    58

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    Basic Information

    Device Name
    INSPIRON LIQUID OXYGEN SYSTEM
    K Number
    K834290
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5655
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Inspiron Corp.
    Date Received
    December 8, 1983
    Decision Date
    February 4, 1984
    Product Code
    BYJ
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BYJ Unit, Liquid-Oxygen, Portable

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