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WAVi Co.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
2
Inspections
4
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1942-2024Class IIWAVi Research EEG Desktop System is comprised of the WAVi Research EEG Desktop Software with InstrucDecember 8, 2023

Recent 510(k) Clearances

K-NumberDeviceDate
K213900WAVi SCAN EEG System and AccessoriesMay 6, 2022
K162460WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode ContactsApril 28, 2017