The following data is part of a premarket notification filed by Neurovirtual Usa, Inc. with the FDA for Maxxi Flow Sensor.
| Device ID | K201495 |
| 510k Number | K201495 |
| Device Name: | Maxxi Flow Sensor |
| Classification | Ventilatory Effort Recorder |
| 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 | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-05 |
| Decision Date | 2020-12-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850008393341 | K201495 | 000 |
| 00850008393334 | K201495 | 000 |