K250022
- 510(k) number
- K250022
- Device name
- HeroTracker Sense
- Applicant
- Voluntis FR
- Product code
- CAF — Nebulizer (Direct Patient Interface)
- Decision date
- 2025-06-30
- Date received
- 2025-01-03
- 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: K250022.pdf
Official FDA record: K250022
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.