K252078
- 510(k) number
- K252078
- Device name
- BreathePal Bilevel (GFM50-MD2201)
- Applicant
- Compal Electronics, Inc. TW
- Product code
- MNS — Ventilator, Continuous, Non-Life-Supporting
- Decision date
- 2026-03-17
- Date received
- 2025-07-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K252078.pdf
Official FDA record: K252078
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.