Device Recall Pentax Rigid Laryngostroboscopes

  • 모델명 / 제조번호(시리얼번호)
    Model #'s 9106 and 9108
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-US (nationwide) and countries of: Albania, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Croatia, Denmark, Ecuador, Egypt, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Oman, Philippines, Portugal, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Trinidad, Turkey, United Arab Emirates, and United Kingdom.
  • 제품 설명
    Rigid Laryngostroboscopes || The Rigid Laryngostroboscopes, Models 9106 and 9108 are intended to observe glottic action with the use of a stroboscopic light source. The instrument is inserted per-orally when indications consistent with the need for observation are observed.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Pentax of America Inc, 3 Paragon Dr, Montvale NJ 07645-1782
  • 제조사 모회사 (2017)
  • Source
    USFDA