K233452
- 510(k) number
- K233452
- Device name
- Vivo 45 LS
- Applicant
- Breas Medical AB SE
- Product code
- NOU — Continuous, Ventilator, Home Use
- Decision date
- 2025-01-13
- Date received
- 2023-10-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K233452.pdf
Official FDA record: K233452
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.