K222262 is an FDA 510(k) clearance for the Sunrise. 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 SA (Namur, BE). The FDA issued a Cleared decision on December 22, 2022, 147 days after receiving the submission on July 28, 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 | K222262 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 28, 2022 |
| Decision Date | December 22, 2022 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| 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. |