510(k) K151781 ยท DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor
| Applicant | Ivy Biomedical Systems, Inc., Branford CT, US |
| Decision | Substantially Equivalent, May 27, 2016 |
| Received | Jul 1, 2015 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K151781
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.