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

    NASO-LARYNGO-PHARYNGOSCOPE

    K Number: K991560 · Decision Jul 13, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    132
    Registration Numbers
    132
    Same Product Code
    161
    Applicant Total
    5
    Review Days
    70

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    Basic Information

    Device Name
    NASO-LARYNGO-PHARYNGOSCOPE
    K Number
    K991560
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4760
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Fiber Imaging Technologies, Inc.
    Date Received
    May 4, 1999
    Decision Date
    July 13, 1999
    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 Fiber Imaging Technologies, Inc.

    K Number Device Name
    K993300 COLDLIGHTSOURCE PL3000
    K992527 URETERO-RENOSCOPE
    K992437 SCHOELLY RIGID ENDOSCOPES
    K992040 FLEXISCOPE II ARTHROSCOPES AND ACCESSORIES