FDA-Device2024-01-31Class II
Snapshot NIR, REF: KD204
KENT IMAGING, INC.
Hazard
Tissue oxygenation measurement system touchscreens may be unresponsive, which may prevent the viewing of oxygenation images.
Sold states
Worldwide - US Nationwide distribution in the states of IN, OH, TX, PA, WI, OR, CO, IL, MO, CA, AZ, IA and the countries of Malaysia.
Affected count
57
Manufactured in
Suite 300, 1210 8 Street SW, N/A, Calgary, N/A, Canada
Products
Snapshot NIR, REF: KD204
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0789-2024Don't want to check this manually?
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