GLOBAL ECG MANAGEMENT SYSTEM (GEMS)— 510(k) K020366

Name: FDA 510(k) clearance K020366
Creator: U.S. Food and Drug Administration
Published: 2002-04-30

Substantially Equivalent

Cardiocomm Solutions, Inc.

FDA 510(k) clearance K020366 for GLOBAL ECG MANAGEMENT SYSTEM (GEMS), Substantially Equivalent on 2002-04-30. Applicant: Cardiocomm Solutions, Inc.. Device class: 2.

Clearance details

Applicant: Cardiocomm Solutions, Inc.
Product code: Code DPS
Device class: Class 2
Regulation: 21 CFR 870.2340
Advisory panel: Cardiovascular
Date received: 2002-02-04
Decision date: 2002-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Victoria, B.C., CA

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

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.

Clearance details

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Adverse events under product code DPS