Pentax

  • Model / Serial
    Model #'s FI-10BS, FI-10P2, FI-10RBS, FI-13BS, FI-13P, FI-13RBS, FI-16BS, FI-16RBS, FI-9BS and FI-9RBS
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam
  • Product Description
    Intubation Scope || Intended to provide optical visualization of, therapeutic access to, and use to facilitate routine or difficult tracheal intubations of the Upper Airway. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Larynx and Trachea. 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

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

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  • 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.
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