510(k) K191000 ยท DSH Recorder, Magnetic Tape, Medical
Carnation Ambulatory Monitor
| Applicant | Bardy Diagnostics, Inc., Seattle WA, US |
| Decision | Substantially Equivalent, May 16, 2019 |
| Received | Apr 16, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K191000
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.