K022297

Substantially Equivalent

GLOBAL ECG MANAGEMENT SYSTEM (GEMS)

Applicant: Cardiocomm Solutions, Inc.
Product code: DSH
Advisory panel: Cardiovascular
Date received: 2002-07-16
Decision date: 2002-09-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Victoria, B.C., CA

Adverse events under product code DSH

product code DSH

Death: 3
Injury: 652
Total: 655

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.