510(k) K011461 ยท LDD Dc-Defibrillator, Low-Energy, (Including Paddles)
ACCESS CARDIOSYSTEMS MANUAL DEFIBRILLATOR
| Applicant | Access Cardiosystems, Inc., Concord MA, US |
| Decision | Substantially Equivalent, May 28, 2002 |
| Received | May 14, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011461
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.