510(k) K170828 ยท DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Cardiac Trigger Monitor
| Applicant | Ivy Biomedical Systems, Inc., Branford CT, US |
| Decision | Substantially Equivalent, May 17, 2017 |
| Received | Mar 20, 2017 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K170828
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.