510(k) K970801 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive
BCI MODEL 6004 NIBP MONITOR (6004)
| Applicant | Bci Intl., Inc., Waukesha WI, US |
| Decision | Substantially Equivalent, Nov 12, 1997 |
| Received | Mar 4, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970801
| 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.