The following data is part of a premarket notification filed by Neurovirtual Usa, Inc. with the FDA for Bwmini Eeg, Bwminihst, Bwmini Psg.
| Device ID | K131335 |
| 510k Number | K131335 |
| Device Name: | BWMINI EEG, BWMINIHST, BWMINI PSG |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | NEUROVIRTUAL USA, INC. 2315 NW 107TH AVE STE 1M27 Doral, FL 33172 |
| Contact | Eduardo Faria |
| Correspondent | Eduardo Faria NEUROVIRTUAL USA, INC. 2315 NW 107TH AVE STE 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 | 2013-05-09 |
| Decision Date | 2015-02-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00867975000288 | K131335 | 000 |
| 00867975000271 | K131335 | 000 |
| 00867975000264 | K131335 | 000 |