510(k) K910935 ยท DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
MODIFIED PYROGEN TESTING
| Applicant | Electromedics, Inc., Englewood CO, US |
| Decision | Substantially Equivalent, May 16, 1991 |
| Received | Feb 14, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K910935
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.