510(k) K091457

NEXSTIM EXIMIA NAVIGATED BRAIN STIMULATION SYSTEM by Nexstim OY — Product Code GWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 2009
Date Received
May 18, 2009
Clearance Type
Abbreviated
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