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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 the device name listed in this FDA 510(k) record. The listed applicant is VivaQuant, Inc.. It received FDA 510(k) clearance on 2019-02-16 under 510(k) 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. The listed applicant is VivaQuant, Inc.. The 510(k) number is K183704.

When did RX-1 Rhythm Express Remote Cardiac Monitoring System receive FDA 510(k) clearance?

RX-1 Rhythm Express Remote Cardiac Monitoring System received FDA 510(k) clearance on 2019-02-16, under 510(k) number K183704.

Who is the listed applicant for RX-1 Rhythm Express Remote Cardiac Monitoring System?

The FDA 510(k) record lists VivaQuant, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05825417Pulmonary Hypertension: Intensification and Personalisation of Combination RxACTIVE_NOT_RECRUITINGNCT05960175Impact of Patient Involvement in Alerts Management of Telemonitoring CPAPACTIVE_NOT_RECRUITINGNCT07752940Smartphone Based-PPG Assessment of REconversion in Persistent Atrial FibrillationNOT_YET_RECRUITING

Other records listing VivaQuant, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Related Devices (Code: DXH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250233PreemptiveAI Clinical SDKMeasure Labs, Inc. (Dba Preemptiveai, Inc.)K250258HeartBeam AIMIGo with 12-L ECG Synthesis Software SystemHeartbeam, Inc.K243438MEMO Patch M (MPT-E08R-UNC01)Huinno Co., Ltd.K243981Hexoskin Medical System (7100-00016)Carre Technologies, Inc.K243003VitalSigns 1-Lead Holter (VSH101)VitalSigns Technology Co., Ltd.K233521QT ECG (QTERD100)QT Medical, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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