K251448
- 510(k) number
- K251448
- Device name
- FL-10000U Respiratory Humidifier
- Applicant
- Flexicare Medical Limited. GB
- Product code
- BTT — Humidifier, Respiratory Gas, (Direct Patient Interfa
- Decision date
- 2026-01-16
- Date received
- 2025-05-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K251448.pdf
Official FDA record: K251448
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.