Device Recall RT5100 Refractor and RT3100 Refractor

  • 모델명 / 제조번호(시리얼번호)
    RT-5100 and RT-3100, various serial numbers.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US distribution only.
  • 제품 설명
    RT-5100 Refractor and RT-3100 Refractor; || Distributed by MARCO Opthalmic: || Manufactured by NIDEK CO., Ltd., Aichi, Japan. || Instrument provides means of positioning spherical and cylindrical lenses, prisms and other optical devices in front of a subject's eyes 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