Pentax

  • Modèle / numéro de série
    Model #EB-1970UK
  • 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
    Ultrasound Bronchoscope || Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access to, the Pulmonary Tract including but not restricted to organs, tissues and subsystems: Nasal Passage, Pharynx, Larynx, Trachea, Bronchial Tree (including access beyond the stem), and underlying areas. The instrument is introduced orally when indications consistent with the requirement 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

143 dispositifs médicaux avec un nom similaire

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  • Modèle / numéro de série
    EB-1170K, EB-1570, EB-1570AK, EB-1570K, EB-1970, EB-1970AK,
  • Description du dispositif
    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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  • Manufacturer
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