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510(k) K201747

8-CH Electroencephalography Amplifier by Hipposcreen Neurotech Corp. — Product Code GWL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 2020
Date Received
June 26, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Amplifier, Physiological Signal
Device Class
Class II
Regulation Number
882.1835
Review Panel
NE
Submission Type

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