Unified Arrhythmia Diagnostic System PocketECG IV— 510(k) K193104

Name: FDA 510(k) clearance K193104
Creator: U.S. Food and Drug Administration
Published: 2020-04-09

Substantially Equivalent

Medicalgorithmics S.A.

FDA 510(k) clearance K193104 for Unified Arrhythmia Diagnostic System PocketECG IV, Substantially Equivalent on 2020-04-09. Applicant: Medicalgorithmics S.A.. Device class: 2.

Clearance details

Applicant: Medicalgorithmics S.A.
Product code: Code DSI
Device class: Class 2
Regulation: 21 CFR 870.1025
Advisory panel: Cardiovascular
Date received: 2019-11-08
Decision date: 2020-04-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Warsaw, PL

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DSI

product code DSI

Death: 170
Injury: 729
Malfunction: 10,680
Total: 11,579

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.