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510(k) K172312

eego amplifiers by Eemagine Medical Imaging Solutions GmbH — Product Code GWL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 2018
Date Received
August 1, 2017
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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