510(k) K032338 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
TRIO MONITOR MODEL 0998-00-0600
| Applicant | Datascope Corp., Mahwh NJ, US |
| Decision | Substantially Equivalent, Feb 11, 2004 |
| Received | Jul 29, 2003 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K032338
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 13, 2004 | Datascope Corp Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm). Terminated |
NWI | None listed |
| Sep 21, 2004 | Datascope Corp Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm). Terminated |
DRT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.