Vivo 1, Vivo 2— 510(k) K240778
Substantially EquivalentBreas Medical AB
FDA 510(k) clearance K240778 for Vivo 1, Vivo 2, Substantially Equivalent on 2024-12-13. Applicant: Breas Medical AB.
Clearance details
- Applicant
- Breas Medical AB
- Product code
- Code MNS
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Molnlycke, SE
Adverse events under product code MNS
product code MNS- Death
- 344
- Injury
- 1,160
- Malfunction
- 8,068
- Total
- 9,572
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.