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

    TEACHER TM

    K Number: K851655 · Decision Jun 20, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    7
    Applicant Total
    1
    Review Days
    59

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    Basic Information

    Device Name
    TEACHER TM
    K Number
    K851655
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Monargue Intl.
    Date Received
    April 22, 1985
    Decision Date
    June 20, 1985
    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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