Unified Arrhythmia Diagnostic System PocketECG IV
FDA 510(k) K193104 · Medicalgorithmics S.A.
510(k) numberK193104
Submission
- Device name
- Unified Arrhythmia Diagnostic System PocketECG IV
- Applicant
- Medicalgorithmics S.A.
Warsaw, PL - Received
- November 8, 2019
- Decision date
- April 9, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DSI – Detector And Alarm, Arrhythmia
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1025
- Specialty
- Cardiovascular
Other 510(k)s with product code DSI
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|---|---|---|---|
| K243349 | BodyGuardian Remote Monitoring System (BGRMS v3.0)DSI · Traditional | Boston Scientific Cardiac Diagnostic… | 01/23/2026SE |
| K250356 | MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)DSI · Traditional | Infobionic, Inc. | 07/29/2025SE |
| K240177 | Zio AT® device (A100A1001)DSI · Traditional | iRhythm Technologies, Inc. | 10/30/2024SE |
| K230265 | MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemDSI · Abbreviated | Infobionic, Inc. | 10/06/2023SE |
| K231276 | SmartCardia 7L PlatformDSI · Traditional | Smartcardia SA | 08/30/2023SE |
| K192732 | BodyGuardian Remote Monitoring SystemDSI · Traditional | Preventice Technologies, Inc. | 03/26/2020SE |
| K190574 | Patient Assistant Model PA97000DSI · Traditional | Medtronic, Inc. | 09/24/2019SE |
| K182532 | Liba3 SystemDSI · Traditional | National Cardiac, Inc. | 05/15/2019SE |
| K181658 | MobileECG 2 BTDSI · Traditional | Memtec Corporation | 03/26/2019SE |
| K173969 | Medicalgorithmics Unified Cardiac Rehabilitation SystemDSI · Abbreviated | Medicalgorithmics S.A. | 07/11/2018SE |
More from Medicalgorithmics S.A.
| 510(k) | Device | Decision |
|---|---|---|
| K253141 | DeepRhythmAIDQK · Traditional | 12/11/2025SE |
| K250932 | DeepRhythmAIDQK · Traditional | 05/27/2025SE |
| K241197 | DeepRhythmAIDQK · Traditional | 12/04/2024SE |
| K232161 | DeepRhythm PlatformDPS · Traditional | 06/20/2024SE |
| K210822 | DeepRhythmAIDQK · Traditional | 07/27/2022SE |
| K210758 | Q PatchMWJ · Traditional | 06/02/2022SE |
| K173969 | Medicalgorithmics Unified Cardiac Rehabilitation SystemDSI · Abbreviated | 07/11/2018SE |
| K152550 | Medicalgorithmics Unified Arrhythmia Diagnosic SystemDSI · Special | 10/08/2015SE |
| K124060 | Medical Gorithmics Unified Arrhythmia Diagnostic SystemDSI · Abbreviated | 02/21/2013SE |
| K112921 | Medicalgorithmics Unified Arrhythmia Diagnostic SystemDSI · Abbreviated | 05/16/2012SE |
Questions and answers
When was Unified Arrhythmia Diagnostic System PocketECG IV cleared by the FDA?
Unified Arrhythmia Diagnostic System PocketECG IV (K193104) received a 510(k) decision of Substantially Equivalent on April 9, 2020, 153 days after the submission was received.
What is the product code of K193104?
The FDA product code is DSI – Detector And Alarm, Arrhythmia, a Class II (moderate risk) device regulated under 21 CFR 870.1025.