Pentax

  • Model / Serial
    Model #'s EG-3630U, FG-38UX, EG-3630UR, FG-34UX, FG-36UX, EG-3830UT, EG-3670URK and EG-3870UTK.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    Ultrasound Gastroscope || Product Usage: || Intended to provide optical visualization of, ultrasonic Visualization of, and therapeutic access to the Upper Gastrointestinal Tract including but not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Small Bowel and underlying areas. The instrument is introduced via per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Pentax Medical Company, 3 Paragon Dr, Montvale NJ 07645-1782
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

143 devices with a similar name

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