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

    MODEL AUDINA ITE HEATING AID

    K Number: K897024 · Decision Apr 18, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    1366
    Applicant Total
    8
    Review Days
    120

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    Basic Information

    Device Name
    MODEL AUDINA ITE HEATING AID
    K Number
    K897024
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.3300
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Audina Hearing Instrument
    Date Received
    December 19, 1989
    Decision Date
    April 18, 1990
    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 Audina Hearing Instrument

    K Number Device Name
    K964816 AUDINA 153 BEHIND THE EAR AND AUDINA 158 BEHIND THE EAR
    K953960 HEARING AID (ALL-IN-THE-EAR)
    K942236 AUDINA PREWIRES (FACEPLATE HEARING AID SERIES)
    K936190 BEHIND THE EAR HEARING AID
    K930271 BEHIND-THE-EAR HEARING AID
    K897023 OVERSIGHT PROGRAM FOR IN-OFFICE ASSEMBLY, HRNG AID
    K820833 AUDICRAFT VIP HEARING AID