OptoMonitor— 510(k) K192340

Substantially Equivalent

Opsens, Inc.

FDA 510(k) clearance K192340 for OptoMonitor, Substantially Equivalent on 2019-12-12. Applicant: Opsens, Inc..

Clearance details

Applicant: Opsens, Inc.
Product code: Code DXO
Advisory panel: Cardiovascular
Date received: 2019-08-28
Decision date: 2019-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Quebec, CA

Download summary PDF View on FDA.gov ↗

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.