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

    PENTAX NASO-PHARYNGO-LARYNGOSCOPE FNL-15P2/15RP2

    K Number: K921707 · Decision Jul 1, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    119
    Registration Numbers
    119
    Same Product Code
    156
    Applicant Total
    67
    Review Days
    82

    Basic Information

    Device Name
    PENTAX NASO-PHARYNGO-LARYNGOSCOPE FNL-15P2/15RP2
    K Number
    K921707
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4760
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    PENTAX PRECISION INSTRUMENT CORP.
    Date Received
    April 10, 1992
    Decision Date
    July 1, 1992
    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 PENTAX PRECISION INSTRUMENT CORP.

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    K031789 EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE
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    K021276 FG-36UX FIBER ULTRASOUND GASTROSCOPE
    K021278 EG-3630UR, ULTRASOUND VIDEO GASTROSCOPE
    K013640 EG-3630UR, ULTRASUND VIDEO GASTROSCOPE
    K010740 FG-36UX, FIBER ULTRASOUND GASTROSCOPE
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