FDA-Device2023-12-13Class II
Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w
AURIS HEALTH INC
Hazard
Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.
Sold states
US Distribution: AK, AL, AZ, CA, CO, CT, DC, DE, FL, GA, IL, IN, KY, MA, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NY, OH, OR, PA, SC, SD, TN, TX, WI & WV.
Affected count
110 units In total
Manufactured in
150 Shoreline Dr, Redwood City, CA, United States
Products
Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0450-2024Don't want to check this manually?
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