BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 30— 510(k) K060546
Substantially EquivalentBreas Medical AB
FDA 510(k) clearance K060546 for BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 30, Substantially Equivalent on 2006-05-26. Applicant: Breas Medical AB. Device class: 2.
Clearance details
- Applicant
- Breas Medical AB
- Product code
- Code MNS
- Device class
- Class 2
- Regulation
- 21 CFR 868.5895
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Molnlycke, Vastra Gotaland, SE
Recent devices under product code MNS
view allMore clearances from Breas Medical AB
view allAdverse 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.