510(k) K162048

EZstim*III Peripheral Nerve Stimulator/Nerve Locator by Halyard Health - Irvine — Product Code KOI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 2016
Date Received
July 25, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve, Peripheral, Electric
Device Class
Class II
Regulation Number
868.2775
Review Panel
AN
Submission Type