K253939
- 510(k) number
- K253939
- Device name
- DeltaWave Nasal Pillow System
- Applicant
- RemSleep Holdings, Inc. GA · US
- Product code
- BZD — Ventilator, Non-Continuous (Respirator)
- Decision date
- 2026-01-07
- Date received
- 2025-12-09
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K253939.pdf
Official FDA record: K253939
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.