FDA-Device2024-11-06Class II
Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear Clip, each
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
64
Manufactured in
15353 Barranca Pkwy, N/A, Irvine, CA, United States
Products
Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear Clip, each
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0268-2025Don't want to check this manually?
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