GLOBAL ECG MANAGEMENT SYSTEM (GEMS)— 510(k) K022297

Name: FDA 510(k) clearance K022297
Creator: U.S. Food and Drug Administration
Published: 2002-09-27

Substantially Equivalent

Cardiocomm Solutions, Inc.

FDA 510(k) clearance K022297 for GLOBAL ECG MANAGEMENT SYSTEM (GEMS), Substantially Equivalent on 2002-09-27. Applicant: Cardiocomm Solutions, Inc.. Device class: 2.

Clearance details

Applicant: Cardiocomm Solutions, Inc.
Product code: Code DSH
Device class: Class 2
Regulation: 21 CFR 870.2800
Advisory panel: Cardiovascular
Date received: 2002-07-16
Decision date: 2002-09-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Victoria, B.C., CA

Download summary PDF View on FDA.gov ↗

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K253293 — VitaloJAK Clinic (Model 7100)2025-12-03
K243650 — Zio® monitor (DFG0001)2025-08-15
K243603 — AeviceMD2025-05-05

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.

Clearance details

Recent devices under product code DSH

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Adverse events under product code DSH