510(k) K954003 ยท MQS System, Hemodialysis, Access Recirculation Monitoring
COBE HEMODYNAMIC RECIRCULATION MONITOR
| Applicant | Cobe Renal Care, Inc., Lakewood CO, US |
| Decision | Substantially Equivalent, Feb 6, 1997 |
| Received | Aug 25, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954003
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.