DEN210015 is an FDA 510(k) submission for the Sunrise Sleep Disorder Diagnostic Aid. This device is classified as a Device For Sleep Apnea Testing Based On Mandibular Movement (Class II - Special Controls, product code QRS).
Submitted by Sunrise (Namur, BE). The FDA issued a Not Cleared (DENG) decision on January 7, 2022.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2376. A Device For Sleep Apnea Testing Based On Mandibular Movement Is A Prescription Device Intended To Aid In Evaluation Of Sleep Apnea During Sleep In Patients Suspected Of Having Sleep Breathing Disorders By Analyzing Sensor Readings Of Mandibular Movement. The Device Is Not Intended As A Substitute For Full Polysomnography Nor Intended To Be Used As An Apnea Monitor..
| 510(k) Number | DEN210015 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | April 02, 2021 |
| Decision Date | January 07, 2022 |
| Days to Decision | 280 days |
| Submission Type | Direct |
| Review Panel | Anesthesiology (AN) |
| Summary | - |
| Product Code | QRS - Device For Sleep Apnea Testing Based On Mandibular Movement |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.2376 |
| Definition | A Device For Sleep Apnea Testing Based On Mandibular Movement Is A Prescription Device Intended To Aid In Evaluation Of Sleep Apnea During Sleep In Patients Suspected Of Having Sleep Breathing Disorders By Analyzing Sensor Readings Of Mandibular Movement. The Device Is Not Intended As A Substitute For Full Polysomnography Nor Intended To Be Used As An Apnea Monitor. |