BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    HI SONIC 2000 DIGITAL HEARING INSTRUMENT

    K Number: K951678 · Decision Jun 7, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    50
    Applicant Total
    3
    Review Days
    57

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    Basic Information

    Device Name
    HI SONIC 2000 DIGITAL HEARING INSTRUMENT
    K Number
    K951678
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3302
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hearing Innovations, Inc.
    Date Received
    April 11, 1995
    Decision Date
    June 7, 1995
    Product Code
    LXB
    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
    LXB Hearing Aid, Bone Conduction

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    Other Clearances by Hearing Innovations, Inc.

    K Number Device Name
    K013253 HISONIC-TRD TINNITUS RELIEF DEVICE
    K963745 MODEL WMR BTE HEARING INSTRUMENT (MODEL WMR)