K170828

Substantially Equivalent

Cardiac Trigger Monitor

Applicant: Ivy Biomedical Systems, Inc.
Product code: DRT
Advisory panel: Cardiovascular
Date received: 2017-03-20
Decision date: 2017-05-17
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Branford, CT, US

Adverse events under product code DRT

product code DRT

Death: 4
Total: 4

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.