FDA-Device2021-03-10Class II
WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI: ORG 9100A/ 00841983102554 ORG 9110A/ 00841983102561 ORG 9700A/No UDI
Nihon Kohden America Inc
Hazard
Incorrect Date Stamp or No Data Transfer on Telemetry Receiver and Transmitter.
Sold states
US - AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS,KY, LA, ME, MA, MD, MI, MS, MS, MO, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA WI, WV and WY.
Affected count
4,436
Manufactured in
90 Icon, Foothill Ranch, CA, United States
Products
WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI: ORG 9100A/ 00841983102554 ORG 9110A/ 00841983102561 ORG 9700A/No UDI
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1162-2021Don't want to check this manually?
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