FDA-Device2024-11-06Class II
Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp. SpO2 Forehead Probe, Adult, 10/Box
Nihon Kohden America Inc
Hazard
Due to oximeters not having FDA market approval or clearance to distribute in the U.S.
Sold states
U.S.: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, KS, MA, MD, MI, MO, MT, NC, ND, NE, NH, OK, PA, SC, TX, VT, WA, and WI. O.U.S.: N/A
Affected count
67
Manufactured in
15353 Barranca Pkwy, N/A, Irvine, CA, United States
Products
Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp. SpO2 Forehead Probe, Adult, 10/Box
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0267-2025Don't want to check this manually?
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