510(k) K011156 ยท DQA Oximeter
BCI 3403 SLEEP SCREENING PULSE OXIMETER
| Applicant | Bci, Inc., Waukesha WI, US |
| Decision | Substantially Equivalent, Jun 14, 2001 |
| Received | Apr 16, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011156
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.