510(k) K243650 · DSH Recorder, Magnetic Tape, Medical
Zio® monitor (DFG0001)
| Applicant | iRhythm Technologies, Inc., San Francisco CA, US |
| Decision | Substantially Equivalent, Aug 15, 2025 |
| Received | Nov 26, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243650
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.