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

    EMERGENCY TRACHEOSTOMY KIT

    K Number: K823872 · Decision Jan 21, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    1
    Applicant Total
    10
    Review Days
    25

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    Basic Information

    Device Name
    EMERGENCY TRACHEOSTOMY KIT
    K Number
    K823872
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.1060
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Omnicon Medical Corp.
    Date Received
    December 27, 1982
    Decision Date
    January 21, 1983
    Product Code
    EWC
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EWC Chamber, Acoustic (For Audiometric Testing)

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