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Ice Neurosystems, Inc.
FDA Regulatory Profile
Summary
Total Recalls
0
510(k) Clearances
3
Inspections
1
Compliance Actions
0
Recent 510(k) Clearances
K-Number
Device
Date
K222706
iCE-SG2 Subcutaneous Electrode Kit
December 6, 2022
K201678
iCE-SG Subcutaneous Electrode Arrays
March 8, 2021
K191868
iCEWav Neuromonitoring Platform
March 31, 2020