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

    VIDEO SCOPE SYSTEM (LARYNGOSCOPE)

    K Number: K944032 · Decision Sep 15, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    2
    Applicant Total
    92
    Review Days
    394

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    Basic Information

    Device Name
    VIDEO SCOPE SYSTEM (LARYNGOSCOPE)
    K Number
    K944032
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4680
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Jedmed Instrument Co.
    Date Received
    August 17, 1994
    Decision Date
    September 15, 1995
    Product Code
    ENZ
    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
    ENZ Telescope, Laryngeal-Bronchial

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