Cleared Special

MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSIC SYSTEM

K152550 · Medicalgorithmics S.A. · Cardiovascular
Oct 2015
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K152550 is an FDA 510(k) clearance for the MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSIC SYSTEM, a Detector And Alarm, Arrhythmia (Class II — Special Controls, product code DSI), submitted by Medicalgorithmics S.A. (Warsaw, PL). The FDA issued a Cleared decision on October 8, 2015, 30 days after receiving the submission on September 8, 2015. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K152550 FDA.gov
FDA Decision Cleared SESE
Date Received September 08, 2015
Decision Date October 08, 2015
Days to Decision 30 days
Submission Type Special
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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