510(k) K081442 ยท LDD Dc-Defibrillator, Low-Energy, (Including Paddles)
HEART SYNC PEDIATRIC, MODEL PED-100
| Applicant | Heart Sync, LLC, Ann Arbor MI, US |
| Decision | Substantially Equivalent, Sep 24, 2008 |
| Received | May 22, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081442
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.