The following data is part of a premarket notification filed by Neurovision Medical Products, Inc. with the FDA for Neurovision Nerve Locator Monitor.
Device ID | K110140 |
510k Number | K110140 |
Device Name: | NEUROVISION NERVE LOCATOR MONITOR |
Classification | Stimulator, Electrical, Evoked Response |
Applicant | NEUROVISION MEDICAL PRODUCTS, INC. 2225 SPERRY AVE, SUITE 1000 Ventura, CA 93003 |
Contact | Christine Vergely |
Correspondent | Christine Vergely NEUROVISION MEDICAL PRODUCTS, INC. 2225 SPERRY AVE, SUITE 1000 Ventura, CA 93003 |
Product Code | GWF |
CFR Regulation Number | 882.1870 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-01-18 |
Decision Date | 2011-09-30 |
Summary: | summary |