510(k) K072736

RHYTHMLINK INTERNATIONAL MONOPOLAR STIMULATING INSTRUMENT by Rhythmlink International, LLC — Product Code ETN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 2008
Date Received
September 27, 2007
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