K240779
- 510(k) number
- K240779
- Device name
- Vivo 3
- Applicant
- Breas Medical AB SE
- Product code
- MNT — Sv70 Ventilator
- Decision date
- 2024-12-13
- Date received
- 2024-03-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
510(k) Summary (official FDA PDF): K240779.pdf
Official FDA record: K240779
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.