510(k) K010261 ยท DRN Device, Counter-Pulsating, External
CARDIOMEDICS ECP SYSTEM
| Applicant | Cardiomedics, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Feb 28, 2001 |
| Received | Jan 29, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K010261
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.