DeviceClearance

Zio AT® device (A100A1001)— 510(k) K240029

Substantially Equivalent

iRhythm Technologies, Inc.

FDA 510(k) clearance K240029 for Zio AT® device (A100A1001), Substantially Equivalent on 2024-10-21. Applicant: iRhythm Technologies, Inc.. Device class: 2.

Clearance details

Applicant
iRhythm Technologies, Inc.
Product code
Code QYX
Device class
Class 2
Regulation
21 CFR 870.1025
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Francisco, CA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code QYX

product code QYX
Death
13
Malfunction
526
Total
539

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.