The following data is part of a premarket notification filed by Neurovirtual Usa, Inc. with the FDA for Maxxi Position Sensor.
| Device ID | K191492 |
| 510k Number | K191492 |
| Device Name: | Maxxi Position Sensor |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | Neurovirtual USA, INC. 3303 W Commercial Blvd #100 Fort Lauderdale, FL 33309 |
| Contact | Eduardo Faria |
| Correspondent | Eduardo Faria Neurovirtual USA, INC. 3303 W Commercial Blvd #100 Fort Lauderdale, FL 33309 |
| Product Code | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-05 |
| Decision Date | 2020-04-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850008393297 | K191492 | 000 |