Device Recall Epic 5100) Refractor and RT 3100 Refractor

  • Modèle / numéro de série
    serial numbers: See attached distribution list. 128 RT -3100 and 2565 RT-5100.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    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

Fabricant

  • Adresse du fabricant
    Nidek Inc, 47651 Westinghouse Dr, Fremont CA 94539-7474
  • Société-mère du fabricant (2017)
  • Source
    USFDA