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510(k) K213930

Brainlab Elements Guide XT, Guide 3.0 by Brainlab AG — Product Code QQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 2022
Date Received
December 16, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Brain Stimulation Programming Planning Software.
Device Class
Class II
Regulation Number
882.5855
Review Panel
NE
Submission Type

The brain stimulation programming planning software is a prescription device intended to assist in planning stimulation programming for implanted brain stimulators.

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