The following data is part of a premarket notification filed by Neurovirtual Usa, Inc. with the FDA for Maxxi Rip Sensor.
| Device ID | K171304 |
| 510k Number | K171304 |
| Device Name: | Maxxi Rip Sensor |
| Classification | Ventilatory Effort Recorder |
| 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 | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-03 |
| Decision Date | 2019-06-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850008393167 | K171304 | 000 |
| 00850008393068 | K171304 | 000 |
| 00850008393075 | K171304 | 000 |
| 00850008393082 | K171304 | 000 |
| 00850008393099 | K171304 | 000 |
| 00850008393105 | K171304 | 000 |
| 00850008393112 | K171304 | 000 |
| 00850008393129 | K171304 | 000 |
| 00850008393136 | K171304 | 000 |
| 00850008393143 | K171304 | 000 |
| 00850008393150 | K171304 | 000 |
| 00850008393051 | K171304 | 000 |