510(k) K233497
K233497 is an FDA 510(k) premarket notification submitted by Somnomed, Inc. for the device "Rest Assure System". The FDA issued a decision of Substantially Equivalent on October 3, 2024. The device falls under product code PLC (Sleep Appliances With Patient Monitoring), a Class II device regulated under 21 CFR 872.5570. Somnomed, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 3, 2024
- Date Received
- October 31, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sleep Appliances With Patient Monitoring
- Device Class
- Class II
- Regulation Number
- 872.5570
- Review Panel
- DE
- Submission Type
For the treatment of night time snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older while also measuring patient compliance to oral appliance therapy.