The following data is part of a premarket notification filed by Neurovirtual Usa, Inc. with the FDA for Bwii Eeg Digital, Model Pv 1652; Bwii Psg Digital, Model Pv 1524.
| Device ID | K062533 |
| 510k Number | K062533 |
| Device Name: | BWII EEG DIGITAL, MODEL PV 1652; BWII PSG DIGITAL, MODEL PV 1524 |
| Classification | Non-normalizing Quantitative Electroencephalograph Software |
| Applicant | NEUROVIRTUAL USA, INC. 2315 NW 107TH AVE. BOX #133 WAREHOUSE 1A16 Doral, FL 33172 |
| Contact | Eduardo Faria |
| Correspondent | Eduardo Faria NEUROVIRTUAL USA, INC. 2315 NW 107TH AVE. BOX #133 WAREHOUSE 1A16 Doral, FL 33172 |
| Product Code | OLT |
| Subsequent Product Code | GWQ |
| Subsequent Product Code | OLV |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-29 |
| Decision Date | 2006-12-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00867975000257 | K062533 | 000 |
| 00867975000240 | K062533 | 000 |