Pentax

  • Modèle / numéro de série
    Model #'s ECY-1530, ECY-1570K, FCY-15P2 and FCY-15RBS
  • 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
    Cystoscope || Intended to provide optical visualization of and therapeutic access to the Urinary Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Urethra to the Bladder. The instrument is introduced via the urethra 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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  • Description du dispositif
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  • Manufacturer
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