Device Classification Name |
Ventilatory Effort Recorder
|
510(k) Number |
K200695 |
Device Name |
MATRx plus |
Applicant |
Zephyr Sleep Technologies |
102, 701 64 Ave SE |
Calgary,
CA
T2H-2C3
|
|
Applicant Contact |
Sabina Bruehlmann |
Correspondent |
Zephyr Sleep Technologies |
102, 701 64 Ave SE |
Calgary,
CA
T2H-2C3
|
|
Correspondent Contact |
Sabina Bruehlmann |
Regulation Number | 868.2375
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/17/2020 |
Decision Date | 08/24/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|