510(k) DEN170090
- Device
- MATRx plus
- Applicant
- Zephyr Sleep Technologies
- 510(k) number
- DEN170090
- Product code
- QCJ
- Decision
- Unknown (DENG)
- Decision date
- 2018-08-23
- Date received
- 2017-12-21
- Regulation
- 872.5571
- Classification name
- Closed Loop Auto Titration Device For Oral Appliances
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Sabrina Bruehlmann
- Address
- 610a 70 Ave. SE Calgary CA T2H-2J6 T2H-2J6
Source Documents#
510(k) summary PDF not indicated by FDA