510(k) K012763 ยท DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
SORIN BIOMEDICA SMART BCD VANGUARD,SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM
| Applicant | Cobe Cardiovascular, Inc., Arvada CO, US |
| Decision | Substantially Equivalent, Nov 15, 2001 |
| Received | Aug 17, 2001 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K012763
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.