510(k) K012915 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
DINAMAP PRO 1000 MONITOR, MODEL 1000
| Applicant | Ge Medical Systems Information Technologies, Tampa FL, US |
| Decision | Substantially Equivalent, Mar 21, 2002 |
| Received | Aug 30, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012915
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 15, 2003 | GE Medical Systems Information Technologies Power cord manufactured by ElectriCord Manufacturing Company , P/N 316579, used with DINAMAP Patient Monitors as Follows: DINAMAP PRO Series, DINAMAP PRO 1000 Monitor under both the Critikon and GE Me Terminated |
MWI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.