BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    GUEDEL AIRWAY

    K Number: K922748 · Decision Jul 10, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    229
    Registration Numbers
    229
    Same Product Code
    56
    Applicant Total
    5
    Review Days
    32

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    Basic Information

    Device Name
    GUEDEL AIRWAY
    K Number
    K922748
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5110
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Oem Medical Div.
    Date Received
    June 8, 1992
    Decision Date
    July 10, 1992
    Product Code
    CAE
    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
    CAE Airway, Oropharyngeal, Anesthesiology

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