Pentax

  • Modelo / Serial
    Model #'s FB-10V, FB015BS, FB-15P, FB-15RBS, FB-15V, FB-18BS, FB-18P, FB-18RBS, FB-18V, FB-19TV, FB-8V, EB--1530T3, EB-1170K, EB01570K, EB-1575K, EB-1970K, EB-1970-TK and EB-1975K
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam
  • Descripción del producto
    Bronchoscope || Intended to provide optical visualization of and therapeutic access to the Airway and Bronchial Tree. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Nasal Passage, Trachea and Bronchial Tree. The instrument is introduced via the mouth or the nose, as decided by the physician, when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Pentax Medical Company, 3 Paragon Dr, Montvale NJ 07645-1782
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA

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    EB-1170K, EB-1570, EB-1570AK, EB-1570K, EB-1970, EB-1970AK,
  • Descripción del producto
    These instruments are intended to provide an ultrasonic and optical visualization of the pulmonary tracts (through a video monitor), for therapeutic access of the pulmonary tract. Which includes (without limitation) organs, tissues and subsystems, in addition to the trachea and bronchial tree beyond the stem. Endoscopy for visualization of organs and body cavities of the lower respiratory system.
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