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510(k) K150220

STM 9000 Basic, STM 9000 Standard, STM 9000 Fast, STM 9000 Ultra-Fast by Eb Neuro S.P.A. — Product Code GWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 2015
Date Received
January 30, 2015
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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