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

    UNIMAX(TM) HEARING AID BTE MODELS:100S, 110C, PPS4

    K Number: K883961 · Decision Oct 31, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    1366
    Applicant Total
    2
    Review Days
    41

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    Basic Information

    Device Name
    UNIMAX(TM) HEARING AID BTE MODELS:100S, 110C, PPS4
    K Number
    K883961
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.3300
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Unimax Hearing Instruments
    Date Received
    September 20, 1988
    Decision Date
    October 31, 1988
    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 Unimax Hearing Instruments

    K Number Device Name
    K864277 UNIMAX ITE & ULTRAMAX-CCR CUSTOM CANAL INSTRUMENTS