510(k) K981939 ยท DQA Oximeter
AUTOCORR PLUS; 3404 OXIMETER/ECG MONITOR
| Applicant | Bci Intl., Inc., Waukesha WI, US |
| Decision | Substantially Equivalent, Aug 20, 1998 |
| Received | Jun 2, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981939
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 21, 2007 | Smiths Medical PM, Inc. BCI Autocorr Plus Pulse Oximeter/ECG/Respiration Monitor, Catalog Numbers, 3404001 (including S) and 3404002 (including E,F, G, and S) Smiths Medical- a part of Smiths Group plc Terminated |
DQA | None listed |
| Dec 19, 2006 | Smiths Medical PM, Inc. BCI 3404 Autocorr Plus Pulse Oximeter/ECG/Respiration Monitor. Smiths Medical PM, Inc. This device is designed to provide full featured monitoring capabilities in a tabletop design. The system fea Terminated |
DQA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.