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510(k) K212325

EEG-acp by Somnomedics GmbH — Product Code GYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 2022
Date Received
July 26, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Electroconductive
Device Class
Class II
Regulation Number
882.1275
Review Panel
NE
Submission Type

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