Vivo 45 LS— 510(k) K193586

Substantially Equivalent

Breas Medical AB

FDA 510(k) clearance K193586 for Vivo 45 LS, Substantially Equivalent on 2021-01-27. Applicant: Breas Medical AB.

Clearance details

Applicant: Breas Medical AB
Product code: Code NOU
Advisory panel: Anesthesiology
Date received: 2019-12-23
Decision date: 2021-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Molnlycke, SE

Download summary PDF View on FDA.gov ↗

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.