510(k) K190593 ยท DQK Computer, Diagnostic, Programmable
Zio XT ECG Monitoring System, Zio AT ECG Monitoring System
| Applicant | iRhythm Technologies, Inc., San Francisco CA, US |
| Decision | Substantially Equivalent, Aug 23, 2019 |
| Received | Mar 7, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190593
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.