510(k) K864503 ยท DWD Suction Control, Intracardiac, Cardiopulmonary Bypass
MODIFIED RLV-2100 B
| Applicant | American Omni Medical, Inc., Costa Mesa CA, US |
| Decision | Substantially Equivalent, Jan 6, 1987 |
| Received | Nov 14, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K864503
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.