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

    PURITAN-BENNETT COMPANION 500 LIQUID OXYGEN SYSTEM

    K Number: K905530 · Decision Mar 1, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    20
    Applicant Total
    110
    Review Days
    81

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    Basic Information

    Device Name
    PURITAN-BENNETT COMPANION 500 LIQUID OXYGEN SYSTEM
    K Number
    K905530
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5935
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Puritan Bennett Corp.
    Date Received
    December 10, 1990
    Decision Date
    March 1, 1991
    Product Code
    BYT
    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
    BYT Ventilator, External Body, Negative Pressure, Adult (Cuirass)

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    K993220 PURITAN-BENNETT HELIOS PORTABLE LIQUID OXYGEN SYSTEM
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