K993341

Substantially Equivalent

INTELLISYSTEM II COLOR MONITOR

Applicant: Merit Medical Systems, Inc.
Product code: MAV
Advisory panel: Cardiovascular
Date received: 1999-10-05
Decision date: 1999-10-25
Decision: Substantially Equivalent
Clearance type: Special
Location: South Jordan, UT, US

Adverse events under product code MAV

product code MAV

Malfunction: 1,433
Total: 1,433

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.