Device Recall Epic 5100) Refractor and RT 3100 Refractor

  • 모델명 / 제조번호(시리얼번호)
    serial numbers: See attached distribution list. 128 RT -3100 and 2565 RT-5100.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution
  • 제품 설명
    RT-5100 (Epic 5100) Refractor and RT 3100 Refractor: || Product Usage: || Instrument providing means of positioning spherical and cylindrical lenses, prisms and other optical devices in front of a subjects eye for purpose of determining refractive error and binocular functions.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Nidek Inc, 47651 Westinghouse Dr, Fremont CA 94539-7474
  • 제조사 모회사 (2017)
  • Source
    USFDA