CARDIS— 510(k) K023015

Name: FDA 510(k) clearance K023015
Creator: U.S. Food and Drug Administration
Published: 2002-09-25

Substantially Equivalent

Schwarzer GmbH

FDA 510(k) clearance K023015 for CARDIS, Substantially Equivalent on 2002-09-25. Applicant: Schwarzer GmbH. Device class: 2.

Clearance details

Applicant: Schwarzer GmbH
Product code: Code DQK
Device class: Class 2
Regulation: 21 CFR 870.1425
Advisory panel: Cardiovascular
Date received: 2002-09-10
Decision date: 2002-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Munich, DE

Download summary PDF View on FDA.gov ↗

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K252978 — ScioCardio ECG Analysis Platform2026-07-09

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.