Devices · VivaQuant Inc.

RX-1 Rhythm Express Remote Cardiac Monitoring System

VivaQuant Inc. is listed for RX-1 Rhythm Express Remote Cardiac Monitoring System (K183704). The FDA list gives February 16, 2019 as the date of the final decision. The lead panel is Cardiovascular, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is DXH. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K183704

Official FDA database record

Date of final decision

February 16, 2019

Company on the FDA list

VivaQuant Inc.

Lead panel

Cardiovascular

Primary product code

DXH

openFDA device name for the code

Transmitters And Receivers, Electrocardiograph, Telephone

Device class

2

Regulation number

870.2920

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary