BREAS VIVO 40 SYSTEM— 510(k) K090113

Substantially Equivalent

Breas Medical AB

FDA 510(k) clearance K090113 for BREAS VIVO 40 SYSTEM, Substantially Equivalent on 2009-05-14. Applicant: Breas Medical AB.

Clearance details

Applicant: Breas Medical AB
Product code: Code MNT
Advisory panel: Anesthesiology
Date received: 2009-01-21
Decision date: 2009-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Molnlycke, SE

Download summary PDF View on FDA.gov ↗

Adverse events under product code MNT

product code MNT

Death: 118
Injury: 324
Malfunction: 25,451
Other: 2
Total: 25,895

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.