K163512

Substantially Equivalent

Zio AT ECG Monitoring System

Applicant: iRhythm Technologies, Inc.
Product code: QYX
Advisory panel: Cardiovascular
Date received: 2016-12-15
Decision date: 2017-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Francisco, CA, US

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.