The following data is part of a premarket notification filed by Neurovision Medical Products, Inc. with the FDA for Paired Hydrogel Electrode.
| Device ID | K110138 |
| 510k Number | K110138 |
| Device Name: | PAIRED HYDROGEL ELECTRODE |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-18 |
| Decision Date | 2011-04-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B066HGELS102 | K110138 | 000 |
| B006HGELSRED102 | K110138 | 000 |
| B006HGELP102 | K110138 | 000 |