Device Classification Name |
closed loop auto titration device for oral appliances
|
De Novo Number |
DEN170090 |
Device Name |
MATRx plus |
Requester |
zephyr sleep technologies |
610a 70 ave se |
calgary,
CA
t2h-2j6
|
|
Contact |
sabrina bruehlmann |
|
Regulation Number | 872.5571
|
Classification Product Code |
|
Date Received | 12/21/2017 |
Decision Date | 08/23/2018 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Dental
|
Review Advisory Committee |
Dental
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|