Cleared Abbreviated

MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM

K112921 · Medicalgorithmics S.A. · Cardiovascular
May 2012
Decision
226d
Days
Class 2
Risk

About This 510(k) Submission

K112921 is an FDA 510(k) clearance for the MEDICALGORITHMICS 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 May 16, 2012, 226 days after receiving the submission on October 3, 2011. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K112921 FDA.gov
FDA Decision Cleared SESE
Date Received October 03, 2011
Decision Date May 16, 2012
Days to Decision 226 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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