510(k) K143067 ยท DSH Recorder, Magnetic Tape, Medical
Carnation Ambulatory Monitor
| Applicant | Bardy Diagnostics, Inc., Vashon Island WA, US |
| Decision | Substantially Equivalent, Dec 22, 2014 |
| Received | Oct 24, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143067
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.