510(k) K022107 ยท DRN Device, Counter-Pulsating, External
CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000
| Applicant | Cardiomedics, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Aug 8, 2002 |
| Received | Jun 28, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K022107
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.