510(k) K142624

Neuromaster G1 MEE200 by Nihon Kohden Corporation — Product Code GWF

K142624 is an FDA 510(k) premarket notification submitted by Nihon Kohden Corporation for the device "Neuromaster G1 MEE200". The FDA issued a decision of Substantially Equivalent on April 24, 2015. The device falls under product code GWF (Stimulator, Electrical, Evoked Response), a Class II device regulated under 21 CFR 882.1870. Nihon Kohden Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2015
Date Received
September 16, 2014
Clearance Type
Traditional
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