510(k) K202138 ยท DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Cardiac Trigger Monitor
| Applicant | Ivy Biomedical Systems, Inc., Branford CT, US |
| Decision | Substantially Equivalent, May 14, 2021 |
| Received | Jul 31, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202138
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.