Cleared Traditional

RX-1 Rhythm Express Remote Cardiac Monitoring System

K183704 · Vivaquant, Inc. · Cardiovascular

Feb 2019

Decision

47d

Days

Class 2

Risk

About This 510(k) Submission

K183704 is an FDA 510(k) clearance for the RX-1 Rhythm Express Remote Cardiac Monitoring System, a Transmitters And Receivers, Electrocardiograph, Telephone (Class II — Special Controls, product code DXH), submitted by Vivaquant, Inc. (St. Paul, US). The FDA issued a Cleared decision on February 16, 2019, 47 days after receiving the submission on December 31, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2920.

Submission Details

510(k) Number	K183704 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 31, 2018
Decision Date	February 16, 2019
Days to Decision	47 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF