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510(k) K173684

g.Estim PRO by G.Tec Medical Engineering GmbH — Product Code GYC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2018
Date Received
December 1, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Electrode, Cortical
Device Class
Class II
Regulation Number
882.1310
Review Panel
NE
Submission Type

Other clearances by G.Tec Medical Engineering GmbH

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  • K123255 — g.HIamp (December 20, 2012)
  • K060803 — G.USBAMP (May 2, 2006)

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