K240177
- 510(k) number
- K240177
- Device name
- Zio AT® device (A100A1001)
- Applicant
- iRhythm Technologies, Inc. CA · US
- Product code
- DSI — Detector And Alarm, Arrhythmia
- Decision date
- 2024-10-30
- Date received
- 2024-01-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K240177.pdf
Official FDA record: K240177
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.