510(k) K020350 ยท DQA Oximeter
BCI 3180 PULSE OXIMETER
| Applicant | Bci, Inc., Waukesha WI, US |
| Decision | Substantially Equivalent, Apr 30, 2002 |
| Received | Feb 4, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K020350
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 2, 2010 | Smiths Medical PM, Inc. BCI 3180 Pulse Oximeter uses power cord WW3005 (Electri-Cord Manufacturing Co., 312 E. Main St., Westfield, PA 16950). Terminated |
DQA | None listed |
| Aug 15, 2008 | Smiths Medical PM, Inc. BCI 3180 Oximeter - Patient monitoring medical device, Manufactured by Smiths Medical PM, Inc. For continuous patient monitoring of blood oxygen levels, pulse rate and pulse strength measurements. Terminated |
DQA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.