FDA-Device2018-08-08Class II
Nicolet¿ Ambulatory EEG
Natus Neurology Inc
Hazard
Potential to be able to import an ambulatory exam for a patient for which the exam was not started.
Sold states
Distributed domestically to AR, AZ, CA, CO, DC, FL, GA, ID, IL, IN, MA, ME, MI, MO, N Y, NC, ND, NJ, NV, NY, PA, TN, TX, VA, WA, WI. Distributed internationally to Australia, Belgium, China, Germany, Hong Kong, Israel, Italy, Jordan, Kuwait, Russia, Slovenia, Tunisia, United Arab Emirates, Vietnam.
Affected count
171 units
Manufactured in
3150 Pleasant View Rd, N/A, Middleton, WI, United States
Products
Nicolet¿ Ambulatory EEG
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2568-2018Don't want to check this manually?
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