K014108

Substantially Equivalent

MAC 5000 ECG ANALYSIS SYSTEM

Applicant: General Electric Medical Systems Information Techn
Product code: DQK
Advisory panel: Cardiovascular
Date received: 2001-12-13
Decision date: 2002-01-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Milwaukee, WI, US

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.