RX-1 Rhythm Express Remote Cardiac Monitoring System

Q: What is the product code of K183704?

The FDA product code is DXH – Transmitters And Receivers, Electrocardiograph, Telephone, a Class II (moderate risk) device regulated under 21 CFR 870.2920.

FDA 510(k) K183704 · VivaQuant, Inc.

Substantially Equivalent

510(k) numberK183704

Submission

Device name: RX-1 Rhythm Express Remote Cardiac Monitoring System
Applicant: VivaQuant, Inc.
St. Paul, MN, US
Received: December 31, 2018
Decision date: February 16, 2019
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA
Third-party review: Yes

Official FDA 510(k) record

Device classification

Product code: DXH – Transmitters And Receivers, Electrocardiograph, Telephone
Device class: Class II (moderate risk)
Regulation: 21 CFR 870.2920
Specialty: Cardiovascular

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More from AliveCor, Inc.

510(k)	Device	Decision
K241179	Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)QYX · Traditional	07/11/2025SE
K200833	RX-1 Rhythm Express Remote Cardiac Monitoring SystemMLO · Traditional	09/02/2020SE

Questions and answers

When was RX-1 Rhythm Express Remote Cardiac Monitoring System cleared by the FDA?

RX-1 Rhythm Express Remote Cardiac Monitoring System (K183704) received a 510(k) decision of Substantially Equivalent on February 16, 2019, 47 days after the submission was received.

What is the product code of K183704?

The FDA product code is DXH – Transmitters And Receivers, Electrocardiograph, Telephone, a Class II (moderate risk) device regulated under 21 CFR 870.2920.