510(k) K163512 ยท QYX Outpatient Cardiac Telemetry
Zio AT ECG Monitoring System
| Applicant | iRhythm Technologies, Inc., San Francisco CA, US |
| Decision | Substantially Equivalent, Jun 2, 2017 |
| Received | Dec 15, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163512
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 4, 2022 | iRhythm Technologies, Inc. Zio AT Clinical Reference Manual, Part: ALB0031, and Zio AT Important Information Pamphlet, Part: ALB0034. For Zio Ambulatory ECG monitoring system Open, Classified |
DSI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.