K254078
- 510(k) number
- K254078
- Device name
- HVT 2.0
- Applicant
- Vapotherm, Inc. NH · US
- Product code
- BTT — Humidifier, Respiratory Gas, (Direct Patient Interfa
- Decision date
- 2026-04-13
- Date received
- 2025-12-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K254078.pdf
Official FDA record: K254078
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.