510(k) K043276 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
DATEX-OHMEDA S/5TM FM WITH L-FICU04 AND L-FICU04A SOFTWARE AND N-FCREC MODULE
| Applicant | Datex-Ohmeda, Needham MA, US |
| Decision | Substantially Equivalent, Dec 23, 2004 |
| Received | Nov 26, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043276
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 18, 2014 | GE Healthcare, LLC DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES.
DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only).
E-miniC and accessories is indicate Terminated |
CCK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.