510(k) K170677

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

K170677 is an FDA 510(k) premarket notification submitted by Neurovision Medical Product, Inc. for the device "Neurovision Nerve Locator Monitor (Nerveana), EMGView Software". The FDA issued a decision of Substantially Equivalent on April 5, 2017. The device falls under product code GWF (Stimulator, Electrical, Evoked Response), a Class II device regulated under 21 CFR 882.1870.

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