510(k) K073415

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

K073415 is an FDA 510(k) premarket notification submitted by Eb Neuro S.P.A. for the device "NEMUS SYSTEM; NEMUS PC PERIPHERAL". The FDA issued a decision of Substantially Equivalent on May 23, 2008. The device falls under product code IKN (Electromyograph, Diagnostic), a Class II device regulated under 21 CFR 890.1375. Eb Neuro S.P.A. has at least 10 other 510(k) clearances on record.

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