510(k) K013089 ยท CAH Filter, Bacterial, Breathing-Circuit
EMS HEPA FILTER AND HME COMBINATIONS
| Applicant | Engineered Medical Systems, Mccordsville IN, US |
| Decision | Substantially Equivalent, Mar 14, 2002 |
| Received | Sep 17, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013089
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.