RX-1 Rhythm Express Remote Cardiac Monitoring System

Transmitters And Receivers, Electrocardiograph, Telephone

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 IDK183704
510k NumberK183704
Device Name:RX-1 Rhythm Express Remote Cardiac Monitoring System
ClassificationTransmitters And Receivers, Electrocardiograph, Telephone
Applicant VivaQuant Inc. 4339 Nancy Place, Suite 100 St. Paul,  MN  55126
ContactBrian Brockway
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeDXH  
CFR Regulation Number870.2920 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2018-12-31
Decision Date2019-02-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00860000272414 K183704 000
00860000272407 K183704 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.