ENTERPRISE ECG ANALYSIS / INTERPRETATION SOFTWARE— 510(k) K131045

Substantially Equivalent

Cardiac Designs, LLC

FDA 510(k) clearance K131045 for ENTERPRISE ECG ANALYSIS / INTERPRETATION SOFTWARE, Substantially Equivalent on 2013-05-29. Applicant: Cardiac Designs, LLC.

Clearance details

Applicant: Cardiac Designs, LLC
Product code: Code DQK
Advisory panel: Cardiovascular
Date received: 2013-04-15
Decision date: 2013-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Monroe, CT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQK

product code DQK

Death: 10
Injury: 225
Malfunction: 2,123
Other: 2
Total: 2,360

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.