K193620

Substantially Equivalent

OptoMonitor 3

Applicant: Opsens, Inc.
Product code: DXO
Advisory panel: Cardiovascular
Date received: 2019-12-26
Decision date: 2020-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Quebec, CA

Adverse events under product code DXO

product code DXO

Death: 10
Injury: 156
Malfunction: 884
Total: 1,050

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.