510(k) K083821 ยท DQA Oximeter
VITAL SIGNS MONITOR
| Applicant | Edan Instruments, Inc., Yonkers NY, US |
| Decision | Substantially Equivalent, May 14, 2009 |
| Received | Dec 22, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083821
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.