510(k) K063560

HILGER DUAL-STIM NERVE STIMULATOR by Wr Medical Electronics Co. — Product Code ETN

K063560 is an FDA 510(k) premarket notification submitted by Wr Medical Electronics Co. for the device "HILGER DUAL-STIM NERVE STIMULATOR". The FDA issued a decision of Substantially Equivalent on January 5, 2007. The device falls under product code ETN (Stimulator, Nerve), a Class II device regulated under 21 CFR 874.1820. Wr Medical Electronics Co. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 2007
Date Received
November 28, 2006
Clearance Type
Abbreviated
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