BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇦🇺 Australia

    NASCOR OXYDOME

    K Number: K905627 · Decision Jun 3, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    10
    Applicant Total
    2
    Review Days
    171

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    Basic Information

    Device Name
    NASCOR OXYDOME
    K Number
    K905627
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5700
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Nascor Pty. , Ltd.
    Date Received
    December 14, 1990
    Decision Date
    June 3, 1991
    Product Code
    BYL
    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
    BYL Tent, Oxygen

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    Other Clearances by Nascor Pty. , Ltd.

    K Number Device Name
    K935126 NASCOR IGLOO