Pentax

  • Modèle / numéro de série
    Model #'s EG-3870CIK, EC-3870CILK
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam
  • Description du dispositif
    Confocal GI Scope || Intended to provide optical visualization of an therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Esophagus, Stomach and Duodenum, and Large Bowel to the Cecum. The instrument is introduced via the mouth or rectum as decided by the anatomy being accessed when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Pentax Medical Company, 3 Paragon Dr, Montvale NJ 07645-1782
  • Société-mère du fabricant (2017)
  • Source
    USFDA

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