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

    MODEL FT40 TRANSONIC(TM) HEARING AID

    K Number: K905516 · Decision Apr 9, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    1366
    Applicant Total
    2
    Review Days
    123

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    Basic Information

    Device Name
    MODEL FT40 TRANSONIC(TM) HEARING AID
    K Number
    K905516
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.3300
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Sonovation, Inc. Dba Avr Sonovation
    Date Received
    December 7, 1990
    Decision Date
    April 9, 1991
    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 Sonovation, Inc. Dba Avr Sonovation

    K Number Device Name
    K920466 EXTEND-EAR