The following data is part of a premarket notification filed by Neurovision Medical Product Inc. with the FDA for Neurovision Nerve Locator Monitor (nerveana), Emgview Software.
Device ID | K170677 |
510k Number | K170677 |
Device Name: | Neurovision Nerve Locator Monitor (Nerveana), EMGView Software |
Classification | Stimulator, Electrical, Evoked Response |
Applicant | Neurovision Medical Product Inc. 353 San Jon Rd Ventura, CA 93001 |
Contact | Christine Vergely |
Correspondent | Christine Vergely Neurovision Medical Product Inc. 353 San Jon Rd Ventura, CA 93001 |
Product Code | GWF |
CFR Regulation Number | 882.1870 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-03-06 |
Decision Date | 2017-04-05 |