510(k) K253939
K253939 is an FDA 510(k) premarket notification submitted by RemSleep Holdings, Inc. for the device "DeltaWave Nasal Pillow System". The FDA issued a decision of Substantially Equivalent on January 7, 2026. The device falls under product code BZD (Ventilator, Non-Continuous (Respirator)), a Class II device regulated under 21 CFR 868.5905. RemSleep Holdings, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 7, 2026
- Date Received
- December 9, 2025
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ventilator, Non-Continuous (Respirator)
- Device Class
- Class II
- Regulation Number
- 868.5905
- Review Panel
- AN
- Submission Type