BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    TYMPANOSTOMY VENTILATION TUBE

    K Number: K960742 · Decision Apr 3, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    115
    Applicant Total
    2
    Review Days
    40

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    Basic Information

    Device Name
    TYMPANOSTOMY VENTILATION TUBE
    K Number
    K960742
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3880
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Advanced Microbotics Corp.
    Date Received
    February 23, 1996
    Decision Date
    April 3, 1996
    Product Code
    ETD
    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
    ETD Tube, Tympanostomy

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    Other Clearances by Advanced Microbotics Corp.

    K Number Device Name
    K961945 TYMPANOSTOMY VENTILATION TUBE