K032338

Substantially Equivalent

TRIO MONITOR MODEL 0998-00-0600

Applicant: Datascope Corp.
Product code: MWI
Advisory panel: Cardiovascular
Date received: 2003-07-29
Decision date: 2004-02-11
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Mahwh, NJ, US

Adverse events under product code MWI

product code MWI

Death: 16
Malfunction: 963
Total: 979

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.