510(k) K021435 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
DINAMAP PRO SERIES MONITOR, MODELS 110N,210N,310N,410N
| Applicant | Ge Medical Systems Information Technologies, Tampa FL, US |
| Decision | Substantially Equivalent, May 22, 2002 |
| Received | May 6, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K021435
| 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.