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

    OXYGUARD

    K Number: K914978 · Decision Jan 10, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    65

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    Basic Information

    Device Name
    OXYGUARD
    K Number
    K914978
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Stantex Pty , Ltd.
    Date Received
    November 6, 1991
    Decision Date
    January 10, 1992
    Product Code
    MNK
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MNK Endoscopic Bite Block

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