RX-1 Rhythm Express Remote Cardiac Monitoring System
K-Number: K200833 · 2020-09-02
ApplicantVivaQuant, Inc.
Decision Date2020-09-02
Product CodeMLO
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
RX-1 Rhythm Express Remote Cardiac Monitoring System is a medical device manufactured by VivaQuant, Inc.. It received FDA 510(k) clearance on 2020-09-02 under approval number K200833. The device is classified under product code MLO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the RX-1 Rhythm Express Remote Cardiac Monitoring System?
RX-1 Rhythm Express Remote Cardiac Monitoring System is a medical device that received FDA 510(k) clearance on 2020-09-02. It is manufactured by VivaQuant, Inc.. The 510(k) number is K200833.
When was RX-1 Rhythm Express Remote Cardiac Monitoring System approved by the FDA?
RX-1 Rhythm Express Remote Cardiac Monitoring System received FDA 510(k) clearance on 2020-09-02, under approval number K200833.
What company makes RX-1 Rhythm Express Remote Cardiac Monitoring System?
RX-1 Rhythm Express Remote Cardiac Monitoring System is manufactured by VivaQuant, Inc..
What is the FDA product code for RX-1 Rhythm Express Remote Cardiac Monitoring System?
The FDA product code for RX-1 Rhythm Express Remote Cardiac Monitoring System is MLO.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.