K844353

Substantially Equivalent

PHYSIOLOGICAL MONITOR 2100

Applicant: Datascope Corp.
Product code: DXN
Advisory panel: Cardiovascular
Date received: 1984-11-09
Decision date: 1985-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paramus, NJ, US

Adverse events under product code DXN

product code DXN

Death: 3
Injury: 169
Malfunction: 1,019
Other: 2
Total: 1,193

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.