DEN170090 is an FDA 510(k) submission for the MATRx plus. This device is classified as a Closed Loop Auto Titration Device For Oral Appliances (Class II - Special Controls, product code QCJ).
Submitted by Zephyr Sleep Technologies (Calgary, CA). The FDA issued a Not Cleared (DENG) decision on August 23, 2018.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5571. 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..
| 510(k) Number | DEN170090 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | December 21, 2017 |
| Decision Date | August 23, 2018 |
| Days to Decision | 245 days |
| Submission Type | Direct |
| Review Panel | Dental (DE) |
| Summary | - |
| Product Code | QCJ - Closed Loop Auto Titration Device For Oral Appliances |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.5571 |
| Definition | 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. |