510(k) K964204 ยท CAH Filter, Bacterial, Breathing-Circuit
ENGSTROM HMEF 1000
| Applicant | Datex Engstrom AB, Mccordsville IN, US |
| Decision | Substantially Equivalent, Nov 13, 1996 |
| Received | Aug 29, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964204
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.