510(k) K083557 ยท DQA Oximeter
BCI WW1030 PULSE OXIMETER
| Applicant | Smiths Medical Pm, Inc., Waukesha WI, US |
| Decision | Substantially Equivalent, May 1, 2009 |
| Received | Dec 2, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083557
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.