The following data is part of a premarket notification filed by Zephyr Sleep Technologies with the FDA for Matrx Plus.
Device ID | K163665 |
510k Number | K163665 |
Device Name: | MATRx Plus |
Classification | Ventilatory Effort Recorder |
Applicant | Zephyr Sleep Technologies 610A 70 Ave SE Calgary, CA T2h-2j6 |
Contact | Sabina Bruehlmann |
Correspondent | Sabina Bruehlmann Zephyr Sleep Technologies 610A 70 Ave SE Calgary, CA T2h-2j6 |
Product Code | MNR |
CFR Regulation Number | 868.2375 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-12-27 |
Decision Date | 2017-05-05 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
MATRX PLUS 88665400 not registered Live/Pending |
Zephyr Sleep Technologies, Inc. 2019-10-23 |