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

    BEAR VENTI--VOICE

    K Number: K834555 · Decision Jan 24, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    12
    Applicant Total
    28
    Review Days
    28

    Basic Information

    Device Name
    BEAR VENTI--VOICE
    K Number
    K834555
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.3375
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Bear Medical Systems, Inc.
    Date Received
    December 27, 1983
    Decision Date
    January 24, 1984
    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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