K240778
- 510(k) number
- K240778
- Device name
- Vivo 1, Vivo 2
- Applicant
- Breas Medical AB SE
- Product code
- MNS — Ventilator, Continuous, Non-Life-Supporting
- 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): K240778.pdf
Official FDA record: K240778
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.