510(k) K100129 ยท DRX Electrode, Electrocardiograph
AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X
| Applicant | Ambu A/S, Glen Burnie MD, US |
| Decision | Substantially Equivalent, Jun 11, 2010 |
| Received | Jan 19, 2010 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K100129
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.