510(k) K170677

Neurovision Nerve Locator Monitor (Nerveana), EMGView Software by Neurovision Medical Product, Inc. — Product Code GWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 2017
Date Received
March 6, 2017
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Electrical, Evoked Response
Device Class
Class II
Regulation Number
882.1870
Review Panel
NE
Submission Type