510(k) K102084

STIMPOD NMS450 NERVE STIMULATOR by Xavant Technology (Pty), Ltd. — Product Code BXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2010
Date Received
July 26, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Stimulator, Nerve, Battery-Powered
Device Class
Class II
Regulation Number
868.2775
Review Panel
AN
Submission Type