510(k) K014211 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
OXYARM CO2
| Applicant | Southmedic, Inc., Mccordsville IN, US |
| Decision | Substantially Equivalent, Jun 11, 2002 |
| Received | Dec 21, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K014211
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 25, 2018 | Southmedic, Inc. Southmedic Oxygen Masks with EtCO2 sampling line part number OM-2125-8, 25 masks per case.
Minimal contact, open oxygen delivery device for use with USP medical grade oxygen and for monitoring breath Terminated |
CCK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.