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

    MIDDLE EAR VIEWER AND FLUID COLLECTOR

    K Number: K862903 · Decision Nov 24, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    142
    Registration Numbers
    142
    Same Product Code
    4
    Applicant Total
    1
    Review Days
    116

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    Basic Information

    Device Name
    MIDDLE EAR VIEWER AND FLUID COLLECTOR
    K Number
    K862903
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.4420
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Steven K. Juhn
    Date Received
    July 31, 1986
    Decision Date
    November 24, 1986
    Product Code
    JZF
    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
    JZF Tube, Ear Suction

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