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

    EG-3630UR

    K Number: K041395 · Decision Jun 9, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    398
    Registration Numbers
    399
    Same Product Code
    408
    Applicant Total
    67
    Review Days
    14

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    Basic Information

    Device Name
    EG-3630UR
    K Number
    K041395
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1570
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pentax Precision Instrument Corp.
    Date Received
    May 26, 2004
    Decision Date
    June 9, 2004
    Product Code
    ITX
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ITX Transducer, Ultrasonic, Diagnostic

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    Other Clearances by Pentax Precision Instrument Corp.

    K Number Device Name
    K041396 FG-36UX FIBER ULTRASOUND GASTROSCOPE
    K041397 EG-3830UT
    K031789 EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE
    K023401 EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE
    K023376 EB-1830T3, VIDEO BRONCHOSCOPE
    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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