Pentax

  • Model / Serial
    Model #EB-1970UK
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam
  • Product Description
    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

Manufacturer

  • Manufacturer Address
    Pentax Medical Company, 3 Paragon Dr, Montvale NJ 07645-1782
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

143 devices with a similar name

Learn more about the data here

  • Model / Serial
    EB-1170K, EB-1570, EB-1570AK, EB-1570K, EB-1970, EB-1970AK,
  • Product Description
    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.
  • Manufacturer
  • Model / Serial
  • Product Description
    (1) - (4) Video soft bronchoscope (5) - (6) Video soft cystoscope (7) Video soft hysteroscope 70141000 (8) - (9) Video flexible nasopharyngeal mirror
  • Manufacturer
  • Model / Serial
  • Product Description
    Video flexible duodenoscope
  • Manufacturer
138 more