RX-1 Rhythm Express Remote Cardiac Monitoring System

Electrocardiograph, Ambulatory, With Analysis Algorithm

VivaQuant Inc.

The following data is part of a premarket notification filed by Vivaquant Inc. with the FDA for Rx-1 Rhythm Express Remote Cardiac Monitoring System.

Pre-market Notification Details

Device IDK200833
510k NumberK200833
Device Name:RX-1 Rhythm Express Remote Cardiac Monitoring System
ClassificationElectrocardiograph, Ambulatory, With Analysis Algorithm
Applicant VivaQuant Inc. 4339 Nancy Place, Suite 100 St. Paul,  MN  55126
ContactBrian Brockway
CorrespondentBrodie Pedersen
Borderless Compliance, LLC 7118 Teakwood Cir Maple Grove,  MN  55369
Product CodeMLO  
CFR Regulation Number870.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-30
Decision Date2020-09-02

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