510(k) K110712

DRYTOUCH SUCTION STIMULATOR PROBE by Neurovision Medical Products, Inc. — Product Code ETN

K110712 is an FDA 510(k) premarket notification submitted by Neurovision Medical Products, Inc. for the device "DRYTOUCH SUCTION STIMULATOR PROBE". The FDA issued a decision of Substantially Equivalent on June 28, 2011. 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
June 28, 2011
Date Received
March 14, 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