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510(k) K162873

MEP Monitor by Tonica Elektronik A/S — Product Code GWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 2017
Date Received
October 13, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Electrical, Evoked Response
Device Class
Class II
Regulation Number
882.1870
Review Panel
NE
Submission Type

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