The following data is part of a premarket notification filed by Neurovirtual Usa, Inc. with the FDA for Maxxigold Electrode 48, Maxxigold Electrode 60, Maxxigold Electrode 96.
| Device ID | K163547 |
| 510k Number | K163547 |
| Device Name: | MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96 |
| Classification | Electrode, Cutaneous |
| Applicant | NEUROVIRTUAL USA, INC. 2315 NW 107TH AVE SUITE #1M27 Doral, FL 33172 |
| Contact | Eduardo Faria |
| Correspondent | Eduardo Faria NEUROVIRTUAL USA, INC. 2315 NW 107TH AVE SUITE #1M27 Doral, FL 33172 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-16 |
| Decision Date | 2017-04-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850008393044 | K163547 | 000 |
| 00850008393365 | K163547 | 000 |
| 00850008393303 | K163547 | 000 |
| 00850008393310 | K163547 | 000 |
| 00867975000295 | K163547 | 000 |
| 00850008393006 | K163547 | 000 |
| 00850008393013 | K163547 | 000 |
| 00850008393020 | K163547 | 000 |
| 00850008393037 | K163547 | 000 |
| 00850008393358 | K163547 | 000 |