510(k) K112426

XIAN FRIENDSHIP DISPOSABLE NERVE STIMULATOR PROBES by Xian Friendship Medical Electronics Co., Ltd. — Product Code ETN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 2012
Date Received
August 23, 2011
Clearance Type
Traditional
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