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

    HALOTHANE VAPORIZER 950, ENFLURANE

    K Number: K841157 · Decision Jun 7, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    56
    Applicant Total
    63
    Review Days
    80

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    Basic Information

    Device Name
    HALOTHANE VAPORIZER 950, ENFLURANE
    K Number
    K841157
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5880
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Siemens Elema AB
    Date Received
    March 19, 1984
    Decision Date
    June 7, 1984
    Product Code
    CAD
    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
    CAD Vaporizer, Anesthesia, Non-Heated

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