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510(k) K202174

Digital NeuroPort Biopotential Signal Processing System by Blackrock Microsystems — Product Code GWL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 2021
Date Received
August 4, 2020
Clearance Type
Special
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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