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

    WILSON EUSTACHIAN TUBAL, SONOGRAPH

    K Number: K823774 · Decision Jan 17, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    34

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    WILSON EUSTACHIAN TUBAL, SONOGRAPH
    K Number
    K823774
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.1925
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Antares Technical Associates, Inc.
    Date Received
    December 14, 1982
    Decision Date
    January 17, 1983
    Product Code
    ETK
    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
    ETK Tube, Toynbee Diagnostic