FDA-Device2020-01-08Class III
NIDEK Specular Microscope, Model CEM-530 - Product Usage: The device provides noncontact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area is analyzed through the captured images.
Nidek, Inc.
Hazard
The electromagnetic noise exceeded the upper limit of the Electromagnetic Compatibility Standard (EMC: IEC 60601-1-2)
Sold states
US Nationwide distribution in the states of AZ, CA, IL, KS, MD, NJ, NY, PA, SC, and VA, as well as PR.
Affected count
13 devices
Manufactured in
47651 Westinghouse Dr, N/A, Fremont, CA, United States
Products
NIDEK Specular Microscope, Model CEM-530 - Product Usage: The device provides noncontact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area is analyzed through the captured images.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0771-2020Don't want to check this manually?
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