510(k) K143711

Reaxon Plus by Medovent GmbH — Product Code JXI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 2015
Date Received
December 29, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cuff, Nerve
Device Class
Class II
Regulation Number
882.5275
Review Panel
NE
Submission Type