HORIZON CARDIOLOGY ECG-MCKESSON'S ECG MANAGEMENT SYSTEM, MODEL 1.0— 510(k) K061905

Substantially Equivalent

Medcon , Ltd.

FDA 510(k) clearance K061905 for HORIZON CARDIOLOGY ECG-MCKESSON'S ECG MANAGEMENT SYSTEM, MODEL 1.0, Substantially Equivalent on 2006-11-08. Applicant: Medcon , Ltd..

Clearance details

Applicant: Medcon , Ltd.
Product code: Code DQK
Advisory panel: Cardiovascular
Date received: 2006-07-05
Decision date: 2006-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, 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.