510(k) K200510— Multi-LinkTM X2 ECG Adapter and Leadwires

Substantially Equivalent

Vyaire Medical, Inc.

Clearance details

Applicant: Vyaire Medical, Inc.
Product code: Code DSA
Advisory panel: Cardiovascular
Date received: 2020-03-02
Decision date: 2020-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mettawa, IL, US

Adverse events under product code DSA

product code DSA

Death: 2
Total: 2

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.