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

    EARPOPPER, MODEL EP-2000, EP-2100, EP-3000

    K Number: K073401 · Decision Mar 14, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    5
    Applicant Total
    29
    Review Days
    101

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    Basic Information

    Device Name
    EARPOPPER, MODEL EP-2000, EP-2100, EP-3000
    K Number
    K073401
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Micromedics, Inc.
    Date Received
    December 4, 2007
    Decision Date
    March 14, 2008
    Product Code
    MJV
    Advisory Committee
    Unknown
    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
    MJV Device, Inflation, Middle Ear

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