510(k) DEN210015
DEN210015 is an FDA 510(k) premarket notification submitted by Sunrise for the device "Sunrise Sleep Disorder Diagnostic Aid". The FDA issued a decision of De Novo Granted on January 7, 2022. The device falls under product code QRS (Device For Sleep Apnea Testing Based On Mandibular Movement), a Class II device regulated under 21 CFR 868.2376. Sunrise has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- January 7, 2022
- Date Received
- April 2, 2021
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device For Sleep Apnea Testing Based On Mandibular Movement
- Device Class
- Class II
- Regulation Number
- 868.2376
- Review Panel
- AN
- Submission Type
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.