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510(k) K152550

MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSIC SYSTEM by Medicalgorithmics S.A. — Product Code DSI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 2015
Date Received
September 8, 2015
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)
  • K193104 — Unified Arrhythmia Diagnostic System PocketECG IV (April 9, 2020)
  • K173969 — Medicalgorithmics Unified Cardiac Rehabilitation System (July 11, 2018)
  • K124060 — MEDICAL GORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM (February 21, 2013)
  • K112921 — MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM (May 16, 2012)

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  • K240177 — Zio AT® device (A100A1001) (October 30, 2024)
  • K230265 — MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System (October 6, 2023)
  • K231276 — SmartCardia 7L Platform (August 30, 2023)
  • K193104 — Unified Arrhythmia Diagnostic System PocketECG IV (April 9, 2020)
  • 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)