K253044
- 510(k) number
- K253044
- Device name
- RXiBreeze PAP System (RXiBreeze 20C)
- Applicant
- Resvent Medical Technology Co., Ltd. CN
- Product code
- BZD — Ventilator, Non-Continuous (Respirator)
- Decision date
- 2026-07-23
- Date received
- 2025-09-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K253044.pdf
Official FDA record: K253044
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.