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510(k) K160280

MagPro R20 by Tonica Elektronik A/S — Product Code GWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 2016
Date Received
February 2, 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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