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

    AURIS AE, AURIS TL, AURIS HS, AURIS AC, AURIS MM, AURIS COE, AURIS CIC

    K Number: K971399 · Decision Jun 13, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    1366
    Applicant Total
    5
    Review Days
    59

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    Basic Information

    Device Name
    AURIS AE, AURIS TL, AURIS HS, AURIS AC, AURIS MM, AURIS COE, AURIS CIC
    K Number
    K971399
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.3300
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    General Hearing Instruments, Inc.
    Date Received
    April 15, 1997
    Decision Date
    June 13, 1997
    Product Code
    ESD
    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
    ESD Hearing Aid, Air-Conduction, Prescription

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    Other Clearances by General Hearing Instruments, Inc.

    K Number Device Name
    K061459 TRANQUIL TRI-BTE
    K974751 TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC
    K943144 AURIS CIC
    K850123 IN-TH-EAR HEARING AID