THE CORE (CARDIAC OUTPATIENT REALTIME ECG) MONITOR— 510(k) K103706

Substantially Equivalent

Applied Cardiac Systems, Inc.

FDA 510(k) clearance K103706 for THE CORE (CARDIAC OUTPATIENT REALTIME ECG) MONITOR, Substantially Equivalent on 2011-08-24. Applicant: Applied Cardiac Systems, Inc..

Clearance details

Applicant: Applied Cardiac Systems, Inc.
Product code: Code QYX
Advisory panel: Cardiovascular
Date received: 2010-12-20
Decision date: 2011-08-24
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Laguna Hills, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code QYX

product code QYX

Death: 13
Malfunction: 526
Total: 539

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.