The following data is part of a premarket notification filed by Neurovision Medical Products, Inc. with the FDA for Neurovision Se (nerveana).
| Device ID | K102862 |
| 510k Number | K102862 |
| Device Name: | NEUROVISION SE (NERVEANA) |
| Classification | Stimulator, Nerve |
| 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 | ETN |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-30 |
| Decision Date | 2010-12-21 |
| Summary: | summary |