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Neuralynx Inc

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
2
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1091-2022Class IIATLAS Stim Headbox-NK For use only with the ATLAS Neurophysiology System. CAUTION--INVESTIGATIONAL DMarch 14, 2022

Recent 510(k) Clearances

K-NumberDeviceDate
K250094Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089); Atlas Stim HApril 14, 2025
K110967ENTERPRISE ELECTROPHYSIOLOGY SYSTEMJune 30, 2011