RX-1 Rhythm Express Remote Cardiac Monitoring System— 510(k) K200833

Name: FDA 510(k) clearance K200833
Creator: U.S. Food and Drug Administration
Published: 2020-09-02

Substantially Equivalent

VivaQuant, Inc.

FDA 510(k) clearance K200833 for RX-1 Rhythm Express Remote Cardiac Monitoring System, Substantially Equivalent on 2020-09-02. Applicant: VivaQuant, Inc.. Device class: 2.

Clearance details

Applicant: VivaQuant, Inc.
Product code: Code MLO
Device class: Class 2
Regulation: 21 CFR 870.2800
Advisory panel: Cardiovascular
Date received: 2020-03-30
Decision date: 2020-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MLO

view all

K261580 — ZBPro Diagnostic (Version 2.0)2026-09-11
K241890 — Philips Holter Analysis System2025-03-21
K240794 — Frontier X Plus2024-11-08
K193177 — CER-S2020-08-26
K182030 — Faros Mobile2018-11-08

More clearances from VivaQuant, Inc.

view all

Data sourced from openFDA. This site is unofficial and independent of the FDA.