510(k) K051092 ยท CCL Analyzer, Gas, Oxygen, Gaseous-Phase
DATEX-OHMEDA S/5 COMPACT AIRWAY MODULE (MODEL FAMILY E-CAIOVX) E-CAIOVX, E-CAIOV, E-CAIO, E-COVX, E-COV, E-CO & ACCESACC
| Applicant | GE Healthcare, Needham MA, US |
| Decision | Substantially Equivalent, May 25, 2005 |
| Received | Apr 28, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K051092
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 28, 2015 | GE Healthcare D-fend, (p/n 876446-HEL), and D-fend+ (p/n 881319-HEL) water trap. Used with Compact Airway Modules E/M-C(Ai)O(V)(X) and Cardiocap/5 monitors.
Product Usage:
Water traps are intended to protect the Terminated |
CCL | None listed |
| Jun 17, 2014 | GE Healthcare, LLC GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is used for monitoring hospital patients respi Terminated |
CCL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.