Device Recall Epic 5100) Refractor and RT 3100 Refractor

  • Modelo / Serial
    serial numbers: See attached distribution list. 128 RT -3100 and 2565 RT-5100.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    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

Fabricante

  • Dirección del fabricante
    Nidek Inc, 47651 Westinghouse Dr, Fremont CA 94539-7474
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA