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

    321Q MINIMUM ENERGY TINNITUS SUPPRESSOR

    K Number: K922572 · Decision Nov 2, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    76
    Applicant Total
    13
    Review Days
    154

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    Basic Information

    Device Name
    321Q MINIMUM ENERGY TINNITUS SUPPRESSOR
    K Number
    K922572
    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
    Microbio-Medics, Inc.
    Date Received
    June 1, 1992
    Decision Date
    November 2, 1992
    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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