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

    UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2)

    K Number: K071462 · Decision Jun 5, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    45
    Applicant Total
    42
    Review Days
    11

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    Basic Information

    Device Name
    UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2)
    K Number
    K071462
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3310
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Siemens Hearing Instruments, Inc.
    Date Received
    May 25, 2007
    Decision Date
    June 5, 2007
    Product Code
    ETW
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ETW Calibrator, Hearing Aid / Earphone And Analysis Systems

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