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

    REFUGE SOUND GENERATOR

    K Number: K041302 · Decision Jul 1, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    76
    Applicant Total
    5
    Review Days
    48

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    Basic Information

    Device Name
    REFUGE SOUND GENERATOR
    K Number
    K041302
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3400
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Micro-Ear Technology, Inc.
    Date Received
    May 14, 2004
    Decision Date
    July 1, 2004
    Product Code
    KLW
    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
    KLW Masker, Tinnitus

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    Other Clearances by Micro-Ear Technology, Inc.

    K Number Device Name
    K972431 MERIDIAN DSP
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    K934149 MICRO-TECH TRU CANAL