510(k) K121931

NONDISPOSABLE STIMULATING INSTRUMENTS by Neurovision Medical Products, Inc. — Product Code ETN

K121931 is an FDA 510(k) premarket notification submitted by Neurovision Medical Products, Inc. for the device "NONDISPOSABLE STIMULATING INSTRUMENTS". The FDA issued a decision of Substantially Equivalent on October 19, 2012. The device falls under product code ETN (Stimulator, Nerve), a Class II device regulated under 21 CFR 874.1820. Neurovision Medical Products, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 2012
Date Received
July 2, 2012
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