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510(k) K213299

Wireless EEG System by Pascall Systems, Inc. — Product Code OLT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 2022
Date Received
October 1, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Non-Normalizing Quantitative Electroencephalograph Software
Device Class
Class II
Regulation Number
882.1400
Review Panel
NE
Submission Type

Analyze electroencephalograph data using conventional methodology to output and display standard electroencephalograph parameters for interpretation by a qualified user.

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