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510(k) K202621

NeuroSENSE Monitoring System, Model NS-901 by Neurowave Systems, Inc. — Product Code OLW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 2021
Date Received
September 10, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Index-Generating Electroencephalograph Software
Device Class
Class II
Regulation Number
882.1400
Review Panel
NE
Submission Type

Analyze electrical activity of the brain by transformation of electroencephalograph signals into a dimensionless index number for use and interpretation by a qualified user.

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