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

    WEARABLE TWENTY-FOUR CHANNEL VIBROTACTILE VOCODER

    K Number: K862471 · Decision Sep 12, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    7
    Applicant Total
    1
    Review Days
    74

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    Basic Information

    Device Name
    WEARABLE TWENTY-FOUR CHANNEL VIBROTACTILE VOCODER
    K Number
    K862471
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Institute of Logopedics
    Date Received
    June 30, 1986
    Decision Date
    September 12, 1986
    Product Code
    LRA
    Advisory Committee
    Unknown
    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
    LRA Hearing Aid, Tactile

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