510(k) K042945 ยท BZD Ventilator, Non-Continuous (Respirator)
AURA CPAP SYSTEM
| Applicant | Aeiomed, Inc., Stoughton WI, US |
| Decision | Substantially Equivalent, Mar 9, 2005 |
| Received | Oct 25, 2004 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K042945
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.