510(k) K031741 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300
| Applicant | Alaris Medical Systems, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Feb 9, 2004 |
| Received | Jun 4, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031741
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 1, 2019 | CareFusion 303, Inc. Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 11634567 and 8300ADXeN933 Terminated |
CCK | None listed |
| Dec 21, 2015 | CareFusion 303, Inc. Alaris EtCO2 Module, Model 8300. A capnograph that continuously monitors end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2), and respiratory rate (RR). Terminated |
CCK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.