510(k) K120536 ยท MKJ Automated External Defibrillators (Non-Wearable)
HEART SYNC PEDIATRIC PHYSIO AED PAD
| Applicant | Heart Sync, Inc., Naples FL, US |
| Decision | Substantially Equivalent, Aug 6, 2012 |
| Received | Feb 22, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120536
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.