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510(k) K193104

Unified Arrhythmia Diagnostic System PocketECG IV by Medicalgorithmics S.A. — Product Code DSI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 2020
Date Received
November 8, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Detector And Alarm, Arrhythmia
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type

Other clearances by Medicalgorithmics S.A.

  • K253141 — DeepRhythmAI (December 11, 2025)
  • K250932 — DeepRhythmAI (May 27, 2025)
  • K241197 — DeepRhythmAI (December 4, 2024)
  • K232161 — DeepRhythm Platform (June 20, 2024)
  • K210822 — DeepRhythmAI (July 27, 2022)
  • K210758 — Q Patch (June 2, 2022)
  • K173969 — Medicalgorithmics Unified Cardiac Rehabilitation System (July 11, 2018)
  • K152550 — MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSIC SYSTEM (October 8, 2015)
  • K124060 — MEDICAL GORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM (February 21, 2013)
  • K112921 — MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM (May 16, 2012)

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  • K231276 — SmartCardia 7L Platform (August 30, 2023)
  • K192732 — BodyGuardian Remote Monitoring System (March 26, 2020)
  • K190574 — Patient Assistant Model PA97000 (September 24, 2019)
  • K182532 — Liba3 System (May 15, 2019)
  • K181658 — MobileECG 2 BT (March 26, 2019)
  • K173969 — Medicalgorithmics Unified Cardiac Rehabilitation System (July 11, 2018)