Device product
Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear Clip, each
Z-0268-2025
Product summary
- Event
- Event 95426
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 64
- Official record key
device-enforcement:Z-0268-2025
Official wording
Reason: Due to oximeters not having FDA market approval or clearance to distribute in the U.S.
Code information: Model num.: 809030007 UDI-DI: 06970758500159 All lot numbers
Distribution pattern: 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
Derived failure modes
-
Unknown
Due to oximeters not having FDA market approval or clearance to distribute in the U.S.