Zio XT ECG Monitoring System, Zio AT ECG Monitoring System— 510(k) K190593

Substantially Equivalent

iRhythm Technologies, Inc.

FDA 510(k) clearance K190593 for Zio XT ECG Monitoring System, Zio AT ECG Monitoring System, Substantially Equivalent on 2019-08-23. Applicant: iRhythm Technologies, Inc..

Clearance details

Applicant: iRhythm Technologies, Inc.
Product code: Code DQK
Advisory panel: Cardiovascular
Date received: 2019-03-07
Decision date: 2019-08-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Francisco, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQK

product code DQK

Death: 10
Injury: 225
Malfunction: 2,123
Other: 2
Total: 2,360

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.