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

    NASO-LARYNGO-PHARYNGOSCOPE

    K Number: K083553 · Decision Jan 16, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    132
    Registration Numbers
    132
    Same Product Code
    161
    Applicant Total
    5
    Review Days
    46

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    Basic Information

    Device Name
    NASO-LARYNGO-PHARYNGOSCOPE
    K Number
    K083553
    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
    Schoelly Imaging, Inc.
    Date Received
    December 1, 2008
    Decision Date
    January 16, 2009
    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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    Other Clearances by Schoelly Imaging, Inc.

    K Number Device Name
    K090800 VS-100 ILLUMINATION AND IMAGING SYSTEM
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    K053412 FLEXISCOPE, MODELS 50MH AND 50 MHC