510(k) K091985 ยท DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
UNIVERSAL PHYSIOLOGICAL MEASUREMENT MODULE
| Applicant | Ivy Biomedical Systems, Inc., Branford CT, US |
| Decision | Substantially Equivalent, Jul 24, 2009 |
| Received | Jul 2, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K091985
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.