510(k) K042130 ยท BZD Ventilator, Non-Continuous (Respirator)
AURA CPAP PATIENT INTERFACE
| Applicant | Aeiomed, Inc., Stoughton WI, US |
| Decision | Substantially Equivalent, Sep 8, 2004 |
| Received | Aug 6, 2004 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K042130
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.