510(k) K053141

NEUROSIGN MOTOR NERVE MONITOR, MODELS NEUROSIGN 400 & 800 by The Magstim Company , Ltd. — Product Code ETN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 2005
Date Received
November 9, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve
Device Class
Class II
Regulation Number
874.1820
Review Panel
EN
Submission Type