510(k) K002116 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
S3 CARDIOPLEGIA CONTROL MODULE VERSION 2.0
| Applicant | Medical Device Consultants, Inc., North Attleboro MA, US |
| Decision | Substantially Equivalent, Aug 9, 2000 |
| Received | Jul 13, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K002116
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.