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FDA 510(k)

RX-1 Rhythm Express Remote Cardiac Monitoring System

K-Number: K183704 · 2019-02-16

ApplicantVivaQuant, Inc.
Decision Date2019-02-16
Product CodeDXH
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 2019-02-16 under approval number K183704. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. 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 2019-02-16. It is manufactured by VivaQuant, Inc.. The 510(k) number is K183704.

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 2019-02-16, under approval number K183704.

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 DXH. This falls under the Hematology category.

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Related PubMed Literature

PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026) PMID: 41619565 Integration of materiovigilance in Unani medicine: A step towards patient safety. Journal of Ayurveda and integrative medicine (2026) PMID: 41491965 From stones to system: integrating kidney stones disease into the cardiovascular-kidney-metabolic continuum. Current opinion in nephrology and hypertension (2026)

Other Devices by VivaQuant, Inc.

K200833RX-1 Rhythm Express Remote Cardiac Monitoring System K241179Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)

Related Devices (Code: DXH)

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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.

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