510(k) K130664 ยท CAH Filter, Bacterial, Breathing-Circuit
HYRDROMAX HMEF
| Applicant | A-M Systems, Bonita Springs FL, US |
| Decision | Substantially Equivalent, Jun 21, 2013 |
| Received | Mar 12, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130664
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.