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

    EB-1830T3, VIDEO BRONCHOSCOPE

    K Number: K023376 · Decision Oct 16, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    163
    Registration Numbers
    163
    Same Product Code
    238
    Applicant Total
    67
    Review Days
    8

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    Basic Information

    Device Name
    EB-1830T3, VIDEO BRONCHOSCOPE
    K Number
    K023376
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    874.4680
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pentax Precision Instrument Corp.
    Date Received
    October 8, 2002
    Decision Date
    October 16, 2002
    Product Code
    EOQ
    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
    EOQ Bronchoscope (Flexible Or Rigid)

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    Other Clearances by Pentax Precision Instrument Corp.

    K Number Device Name
    K041396 FG-36UX FIBER ULTRASOUND GASTROSCOPE
    K041395 EG-3630UR
    K041397 EG-3830UT
    K031789 EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE
    K023401 EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE
    K021276 FG-36UX FIBER ULTRASOUND GASTROSCOPE
    K021278 EG-3630UR, ULTRASOUND VIDEO GASTROSCOPE
    K013640 EG-3630UR, ULTRASUND VIDEO GASTROSCOPE
    K010740 FG-36UX, FIBER ULTRASOUND GASTROSCOPE
    K964815 AP-4000, AIR PULSE SENSORY STIMULATOR
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