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

    EDINBURGH MASKER

    K Number: K800445 · Decision Mar 12, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    13

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    Basic Information

    Device Name
    EDINBURGH MASKER
    K Number
    K800445
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.5840
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Foundation For Fluency, Inc.
    Date Received
    February 28, 1980
    Decision Date
    March 12, 1980
    Product Code
    KTH
    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
    KTH Device, Anti-Stammering

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