510(k) K083854 ยท DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
CARDIAC TRIGGER, MODEL: CTM300
| Applicant | Ivy Biomedical Systems, Inc., Branford CT, US |
| Decision | Substantially Equivalent, Feb 13, 2009 |
| Received | Dec 24, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K083854
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.