510(k) K073415

NEMUS SYSTEM; NEMUS PC PERIPHERAL by Eb Neuro S.P.A. — Product Code IKN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 2008
Date Received
December 4, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electromyograph, Diagnostic
Device Class
Class II
Regulation Number
890.1375
Review Panel
NE
Submission Type