510(k) K140400

ES2 NEUROMONITORING ACCESSORY INSTRUMENTS by Stryker Corporation — Product Code ETN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 2014
Date Received
February 18, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve
Device Class
Class II
Regulation Number
874.1820
Review Panel
EN
Submission Type