510(k) K100121 ยท BZD Ventilator, Non-Continuous (Respirator)
MODEL 300157 CPAP SYSTEM
| Applicant | Aeiomed, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Jul 13, 2010 |
| Received | Jan 15, 2010 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K100121
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.