510(k) K053550 ยท DRX Electrode, Electrocardiograph
AMBU BLUE SENSOR NEO AND NEO X
| Applicant | Ambu A/S, Glen Burnie MD, US |
| Decision | Substantially Equivalent, Oct 25, 2006 |
| Received | Dec 20, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053550
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.