510(k) K113862 ยท DSH Recorder, Magnetic Tape, Medical
ZIO PATCH
| Applicant | iRhythm Technologies, Inc., San Francisco CA, US |
| Decision | Substantially Equivalent, Feb 6, 2012 |
| Received | Dec 30, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K113862
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.