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

    VIBRO-COM COMMUNICATOR #8827

    K Number: K813057 · Decision Dec 2, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    7
    Applicant Total
    1
    Review Days
    34

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    Basic Information

    Device Name
    VIBRO-COM COMMUNICATOR #8827
    K Number
    K813057
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Sonic Systems, Inc.
    Date Received
    October 29, 1981
    Decision Date
    December 2, 1981
    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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