Pentax

  • Modèle / numéro de série
    Model #'s FD-34V and ED-3490TK
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    Duodenoscope || Product Usage: || Intended to provide optical visualization of and therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, and Large Bowel to the Cecum. The instrument is introduced via the mouth or rectum as decided by the 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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