510(k) DEN170090
DEN170090 is an FDA 510(k) premarket notification submitted by Zephyr Sleep Technologies for the device "MATRx plus". The FDA issued a decision of De Novo Granted on August 23, 2018. The device falls under product code QCJ (Closed Loop Auto Titration Device For Oral Appliances), a Class II device regulated under 21 CFR 872.5571. Zephyr Sleep Technologies has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- August 23, 2018
- Date Received
- December 21, 2017
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Closed Loop Auto Titration Device For Oral Appliances
- Device Class
- Class II
- Regulation Number
- 872.5571
- Review Panel
- DE
- Submission Type
A closed-loop autotitration device for intraoral appliances uses a feedback control to record changes in the patients respiratory status related to repositioning of the mandible during an overnight study. The data are analyzed by a Healthcare Provider and can then be used to prospectively identify patients with mild to moderate obstructive sleep apnea who may be suitable for therapy with an oral appliance and to recommend a target mandibular position.