Device Recall AUTO REF/KERATOMETER ARK1s

  • Modèle / numéro de série
    Model No. ARK-1s, Serial No. 620337, 620340, 620341, 620343, 620345, 620349, 620350, 620355, 620356, 620359, 620363, 620370, 620371, 620374, 620376, 620377, 620380, 620381, 620384, 620387, 620389, 620391, 620394, 620398, 620400, 620403, 620404, 620407, 620410, 620412, 620415, 620417, 620418, 620420, 620422, 620425, 620427, 620429, 620433, 620435, 620437, 620440, 620444, 620445, 620447, 620450, 620452, 620454, 620455, 620459, 620462, 620464, 620466, 620469, 620471, 620474, 620477, 620478, 620480, 620482, 620485, 620487, 620489.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Distributed domestically to AK, AL, AR, CA, CO, DE, FL, GA, ID, IL, IN, MD, MI, MO, MT, NM, NY, OH, OK, PA, SC, TN, TX, VA, WA, WV.
  • Description du dispositif
    AUTO REF/KERATOMETER ARK-1s
  • Manufacturer
  • 1 Event

Fabricant

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