The following data is part of a premarket notification filed by Zephyr Sleep Technologies with the FDA for Matrx Plus.
| Device ID | K181996 |
| 510k Number | K181996 |
| Device Name: | MATRx Plus |
| Classification | Ventilatory Effort Recorder |
| Applicant | Zephyr Sleep Technologies 102, 701 64 Ave SE Calgary, CA T2h-2c3 |
| Contact | Sabina Bruehlmann |
| Correspondent | Sabina Bruehlmann Zephyr Sleep Technologies 102, 701 64 Ave SE Calgary, CA T2h-2c3 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-26 |
| Decision Date | 2018-11-21 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MATRX PLUS 88665400 not registered Live/Pending |
Zephyr Sleep Technologies, Inc. 2019-10-23 |