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

    ITE HEARING AID, SOUND MED OPAL MODEL

    K Number: K903863 · Decision Oct 9, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    1366
    Applicant Total
    9
    Review Days
    71

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    Basic Information

    Device Name
    ITE HEARING AID, SOUND MED OPAL MODEL
    K Number
    K903863
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.3300
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Improved Hearing Service, Inc.
    Date Received
    July 30, 1990
    Decision Date
    October 9, 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 Improved Hearing Service, Inc.

    K Number Device Name
    K903861 ITE HEARING AID, SOUND MED GOLDEN NUGGET MODEL
    K903415 ITE HEARING AID, SOUND MED EMERALD MODEL
    K903862 ITE HEARING AID, SOUND MED RUBY MODEL
    K903860 ITE HEARING AID, SAAPHIRE MODEL
    K903864 ITE HEARING AID, PEARL MODEL
    K903865 ITE HEARING AID, SOUND MED AMETHYST MODEL
    K903859 ITE HEARING AID, DIAMOND MODEL
    K902290 ITE HEARING AID MODEL PALOMINO