Cleared Special

Unified Arrhythmia Diagnostic System PocketECG IV

K193104 · Medicalgorithmics S.A. · Cardiovascular
Apr 2020
Decision
153d
Days
Class 2
Risk

About This 510(k) Submission

K193104 is an FDA 510(k) clearance for the Unified Arrhythmia Diagnostic System PocketECG IV, a Detector And Alarm, Arrhythmia (Class II — Special Controls, product code DSI), submitted by Medicalgorithmics S.A. (Warsaw, PL). The FDA issued a Cleared decision on April 9, 2020, 153 days after receiving the submission on November 8, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K193104 FDA.gov
FDA Decision Cleared SESE
Date Received November 08, 2019
Decision Date April 09, 2020
Days to Decision 153 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DSI — Detector And Alarm, Arrhythmia
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1025

Similar Devices — DSI Detector And Alarm, Arrhythmia

All 397
BodyGuardian Remote Monitoring System (BGRMS v3.0)
K243349 · Boston Scientific Cardiac Diagnostic Technologies, Inc. · Jan 2026
MoMe ARC? Wireless Ambulatory ECG Monitoring and Detection System (32000)
K250356 · Infobionic, Inc. · Jul 2025
Zio AT? device (A100A1001)
K240177 · iRhythm Technologies, Inc. · Oct 2024
MoMe? ARC Wireless Ambulatory ECG Monitoring and Detection System
K230265 · Infobionic, Inc. · Oct 2023
SmartCardia 7L Platform
K231276 · Smartcardia SA · Aug 2023
BodyGuardian Remote Monitoring System
K192732 · Preventice Technologies, Inc. · Mar 2020