BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇿🇦 South Africa

    Trachealator

    K Number: K211894 · Decision Nov 24, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    32
    Applicant Total
    2
    Review Days
    156

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    Basic Information

    Device Name
    Trachealator
    K Number
    K211894
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4680
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Disa Medinotec
    Date Received
    June 21, 2021
    Decision Date
    November 24, 2021
    Product Code
    KTI
    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
    KTI Bronchoscope Accessory

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