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

    AMERICAN ARTIFICIAL LARYNX

    K Number: K914816 · Decision Feb 12, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    12
    Applicant Total
    1
    Review Days
    476

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    Basic Information

    Device Name
    AMERICAN ARTIFICIAL LARYNX
    K Number
    K914816
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.3375
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ultravoice, Ltd.
    Date Received
    October 25, 1991
    Decision Date
    February 12, 1993
    Product Code
    ESE
    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
    ESE Larynx, Artificial (Battery-Powered)

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