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

    ENTITY NASOVIEW LED NASOPHARYNGOSCOPE, MODEL 006105

    K Number: K080622 · Decision Apr 2, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    132
    Registration Numbers
    132
    Same Product Code
    161
    Applicant Total
    2
    Review Days
    28

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    Basic Information

    Device Name
    ENTITY NASOVIEW LED NASOPHARYNGOSCOPE, MODEL 006105
    K Number
    K080622
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    874.4760
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Optim, Inc.
    Date Received
    March 5, 2008
    Decision Date
    April 2, 2008
    Product Code
    EOB
    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
    EOB Nasopharyngoscope (Flexible Or Rigid)

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