Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)— 510(k) K241179

Substantially Equivalent

VivaQuant, Inc.

FDA 510(k) clearance K241179 for Rhythm Express Remote Cardiac Monitoring System (RX-1 mini), Substantially Equivalent on 2025-07-11. Applicant: VivaQuant, Inc..

Clearance details

Applicant: VivaQuant, Inc.
Product code: Code QYX
Advisory panel: Cardiovascular
Date received: 2024-04-29
Decision date: 2025-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arden Hills, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code QYX

product code QYX

Death: 13
Malfunction: 526
Total: 539

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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