Cleared Abbreviated

Medicalgorithmics Unified Cardiac Rehabilitation System

K173969 · Medicalgorithmics S.A. · Cardiovascular
Jul 2018
Decision
194d
Days
Class 2
Risk

About This 510(k) Submission

K173969 is an FDA 510(k) clearance for the Medicalgorithmics Unified Cardiac Rehabilitation 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 July 11, 2018, 194 days after receiving the submission on December 29, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K173969 FDA.gov
FDA Decision Cleared SESE
Date Received December 29, 2017
Decision Date July 11, 2018
Days to Decision 194 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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