FDA-Device2023-06-28Class II
Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503
Masimo Corporation
Hazard
TC-I tip clip sensor may produce readings outside the accuracy specification.
Sold states
US: AK , AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY OUS: Argentina, Australia, Austria, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Gibraltar, Guernsey, Hong Kong, Hungary, Iceland, India, Israel, Italy, Japan, Jersey, Jordan, Kenya, Lebanon, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Palestinian Territory, Poland, Portugal, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam.
Affected count
123,745 units
Manufactured in
52 Discovery, Irvine, CA, United States
Products
Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1986-2023Don't want to check this manually?
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