FDA-Device2016-04-20Class II
Neurotherm NT2000iX RF Generator Model Number: RFG-NT -2000iX
Neurotherm, Inc.
Hazard
NT2000iX software shipped with the international setting turned on. The international settings include access to Corodotomy, Bi-Polar, and No Temperature modes were not cleared in the United States for use.
Sold states
CA, CO, IA, ME, NJ, NY, SC, TX, WI
Affected count
25
Manufactured in
600 Research Dr Ste 1, N/A, Wilmington, MA, United States
Products
Neurotherm NT2000iX RF Generator Model Number: RFG-NT -2000iX
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1361-2016Don't want to check this manually?
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