510(k) K031742 ยท DQA Oximeter
BCI 6004 NIBP MONITOR WITH NELLCOR PULSE OXIMETER
| Applicant | Bci, Inc., Waukesha WI, US |
| Decision | Substantially Equivalent, Aug 18, 2003 |
| Received | Jun 4, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031742
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 25, 2008 | Smiths Medical PM, Inc. BCI Non Invasive Blood Pressure Monitor
Product/Catalog number 6004, Terminated |
DXN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.