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510(k) K124060

MEDICAL GORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM by Medicalgorithmics S.A. — Product Code DSI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 2013
Date Received
December 31, 2012
Clearance Type
Abbreviated
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.

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  • 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)
  • K152550 — MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSIC SYSTEM (October 8, 2015)
  • K112921 — MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM (May 16, 2012)

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  • K192732 — BodyGuardian Remote Monitoring System (March 26, 2020)
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