Medical Device Manufacturer · US , New York , NY

Medicalgorithmics S.A.

11 submissions · 11 cleared · Since 2012
11
Total
11
Cleared
0
Denied

Medicalgorithmics S.A. — FDA 510(k) Submissions

Medicalgorithmics S.A. has submitted 11 FDA 510(k) premarket notifications since 2012, of which 11 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Detector And Alarm, Arrhythmia, Computer, Diagnostic, Programmable, Electrocardiograph, Ambulatory (without Analysis), Electrocardiograph . Use the specialty filter in the sidebar to narrow results.

11 devices
1–11 of 11
DeepRhythmAI
K253141 · DQK Computer, Diagnostic,... · Cardiovascular
Dec 2025 77d
DeepRhythmAI
K250932 · DQK Computer, Diagnostic,... · Cardiovascular
May 2025 60d
DeepRhythmAI
K241197 · DQK Computer, Diagnostic,... · Cardiovascular
Dec 2024 218d
DeepRhythm Platform
K232161 · DPS Electrocardiograph · Cardiovascular
Jun 2024 336d
DeepRhythmAI
K210822 · DQK Computer, Diagnostic,... · Cardiovascular
Jul 2022 495d
Q Patch
K210758 · MWJ Electrocardiograph,... · Cardiovascular
Jun 2022 444d
Unified Arrhythmia Diagnostic System PocketECG IV
K193104 · DSI Detector And Alarm,... · Cardiovascular
Apr 2020 153d
Medicalgorithmics Unified Cardiac Rehabilitation System
K173969 · DSI Detector And Alarm,... · Cardiovascular
Jul 2018 194d
MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSIC SYSTEM
K152550 · DSI Detector And Alarm,... · Cardiovascular
Oct 2015 30d
MEDICAL GORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM
K124060 · DSI Detector And Alarm,... · Cardiovascular
Feb 2013 52d
MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM
K112921 · DSI Detector And Alarm,... · Cardiovascular
May 2012 226d
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