K233415
- 510(k) number
- K233415
- Device name
- DELTAWAVE Nasal Pillows System
- Applicant
- Remsleep Holdings FL · US
- Product code
- BZD — Ventilator, Non-Continuous (Respirator)
- Decision date
- 2024-07-02
- Date received
- 2023-10-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K233415.pdf
Official FDA record: K233415
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.