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

    AUDINA 153 BEHIND THE EAR AND AUDINA 158 BEHIND THE EAR

    K Number: K964816 · Decision Jan 17, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    1366
    Applicant Total
    8
    Review Days
    49

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    Basic Information

    Device Name
    AUDINA 153 BEHIND THE EAR AND AUDINA 158 BEHIND THE EAR
    K Number
    K964816
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.3300
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Audina Hearing Instrument
    Date Received
    November 29, 1996
    Decision Date
    January 17, 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 Audina Hearing Instrument

    K Number Device Name
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    K942236 AUDINA PREWIRES (FACEPLATE HEARING AID SERIES)
    K936190 BEHIND THE EAR HEARING AID
    K930271 BEHIND-THE-EAR HEARING AID
    K897024 MODEL AUDINA ITE HEATING AID
    K897023 OVERSIGHT PROGRAM FOR IN-OFFICE ASSEMBLY, HRNG AID
    K820833 AUDICRAFT VIP HEARING AID