K160481

Substantially Equivalent

Vivo 60

Applicant: Breas Medical AB
Product code: NOU
Advisory panel: Anesthesiology
Date received: 2016-02-22
Decision date: 2016-11-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Molnlycke Vastra Gotalands Lan, SE

Adverse events under product code NOU

product code NOU

Death: 65
Injury: 138
Malfunction: 3,664
Other: 1
Total: 3,868

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.