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510(k) K203331

Quick-20m by Cgx, LLC — Product Code GWL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 2021
Date Received
November 12, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

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