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

    COMFORTAID HEARING AID

    K Number: K964680 · Decision Jan 24, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    1366
    Applicant Total
    2
    Review Days
    63

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    Basic Information

    Device Name
    COMFORTAID HEARING AID
    K Number
    K964680
    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
    Ethical Hearing Instruments
    Date Received
    November 22, 1996
    Decision Date
    January 24, 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 Ethical Hearing Instruments

    K Number Device Name
    K962012 ETHICAL HEARING INSTRUMENTS/WIZARD HEARING PROFILE TESTER