DeviceClearance

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.. Device class: 2.

Clearance details

Applicant
iRhythm Technologies, Inc.
Product code
Code DQK
Device class
Class 2
Regulation
21 CFR 870.1425
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Francisco, CA, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code DQK

view all

More clearances from iRhythm Technologies, Inc.

view all

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, through . 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.