The following data is part of a premarket notification filed by Neurovirtual Usa, Inc. with the FDA for Bwiii Eeg, Bwiii Eeg Plus, Bwiii Psg, Bwiii Psg Plus.
| Device ID | K112107 |
| 510k Number | K112107 |
| Device Name: | BWIII EEG, BWIII EEG PLUS, BWIII PSG, BWIII PSG PLUS |
| Classification | Full-montage Standard Electroencephalograph |
| 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 | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-22 |
| Decision Date | 2011-10-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00867975000233 | K112107 | 000 |
| 00850008393181 | K112107 | 000 |
| 00850008393198 | K112107 | 000 |
| 00850008393204 | K112107 | 000 |
| 00850008393211 | K112107 | 000 |
| 00850008393228 | K112107 | 000 |
| 00850008393235 | K112107 | 000 |
| 00850008393242 | K112107 | 000 |
| 00850008393259 | K112107 | 000 |
| 00867975000202 | K112107 | 000 |
| 00867975000219 | K112107 | 000 |
| 00867975000226 | K112107 | 000 |
| 00850008393174 | K112107 | 000 |