Cleared Traditional

RX-1 Rhythm Express Remote Cardiac Monitoring System

K200833 · Vivaquant, Inc. · Cardiovascular

Sep 2020

Decision

156d

Days

Class 2

Risk

About This 510(k) Submission

K200833 is an FDA 510(k) clearance for the RX-1 Rhythm Express Remote Cardiac Monitoring System, a Electrocardiograph, Ambulatory, With Analysis Algorithm (Class II — Special Controls, product code MLO), submitted by Vivaquant, Inc. (St. Paul, US). The FDA issued a Cleared decision on September 2, 2020, 156 days after receiving the submission on March 30, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2800.

Submission Details

510(k) Number	K200833 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 30, 2020
Decision Date	September 02, 2020
Days to Decision	156 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF