Cleared Abbreviated

MEDICAL GORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM

K124060 · Medicalgorithmics S.A. · Cardiovascular
Feb 2013
Decision
52d
Days
Class 2
Risk

About This 510(k) Submission

K124060 is an FDA 510(k) clearance for the MEDICAL GORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM, a Detector And Alarm, Arrhythmia (Class II — Special Controls, product code DSI), submitted by Medicalgorithmics S.A. (New York, US). The FDA issued a Cleared decision on February 21, 2013, 52 days after receiving the submission on December 31, 2012. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K124060 FDA.gov
FDA Decision Cleared SESE
Date Received December 31, 2012
Decision Date February 21, 2013
Days to Decision 52 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DSI — Detector And Alarm, Arrhythmia
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1025

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