FDA-Device2018-04-18Class II
AUTO REF/KERATOMETER ARK-1s
Nidek Inc.
Hazard
There is possibly a difference between the measured dioptric value of the subjective measurement mode and the objective measurement mode on ARK-1s.
Sold states
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.
Affected count
63 untis
Manufactured in
47651 Westinghouse Dr, Fremont, CA, United States
Products
AUTO REF/KERATOMETER ARK-1s
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1348-2018Don't want to check this manually?
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