K240029
- 510(k) number
- K240029
- Device name
- Zio AT® device (A100A1001)
- Applicant
- iRhythm Technologies, Inc. CA · US
- Product code
- QYX — Outpatient Cardiac Telemetry
- Decision date
- 2024-10-21
- Date received
- 2024-01-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K240029.pdf
Official FDA record: K240029
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.