510(k) K864619 ยท KRL Detector, Bubble, Cardiopulmonary Bypass
CAPS LOW LEVEL DETECTOR & DETECTOR/BUBBLE MONITOR
| Applicant | Shiley, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Feb 3, 1987 |
| Received | Nov 24, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K864619
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.