510(k) K870976 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
ONGUARD 1000, CATALOG #043611-000 & 043611-001
| Applicant | Cobe Laboratories, Inc., Lakewood CO, US |
| Decision | Substantially Equivalent, May 6, 1987 |
| Received | Mar 10, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K870976
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.