K251888
- 510(k) number
- K251888
- Device name
- VPAP Pediatric Face Mask
- Applicant
- Hsiner Co., Ltd. TW
- Product code
- CBK — Ventilator, Continuous, Facility Use
- Decision date
- 2026-03-12
- Date received
- 2025-06-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K251888.pdf
Official FDA record: K251888
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.