510(k) K072092

XPOD/XMAP NERVE STIMULATOR by Xavant Technology (Pty), Ltd. — Product Code BXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 2007
Date Received
July 30, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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