510(k) K022740 ยท MLD Monitor, St Segment With Alarm
DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU02 & L-CICU02A SOFTWARE
| Applicant | Datex-Ohmeda, Needham MA, US |
| Decision | Substantially Equivalent, Nov 14, 2002 |
| Received | Aug 19, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K022740
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 1, 2009 | GE Medical Systems Information Tecnology Datex-Ohmeda S/5 Critical Care Monitor with L-CICU01, L-CICU02A, L-ICU05 & L-ICUO5A software.
CCM
Indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respirato Terminated |
MLD | None listed |
| Sep 1, 2009 | GE Medical Systems Information Tecnology Datex-Ohmeda S/5 Compact Critical Care Monitor with L-CICU01, L-CICU02A, L-ICU05 & L-ICUO5A software.
CCCM
Indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), res Terminated |
MLD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.