510(k) K131494 ยท MKJ Automated External Defibrillators (Non-Wearable)
HEART SYNC
| Applicant | Heart Sync, Inc., Naples FL, US |
| Decision | Substantially Equivalent, Sep 16, 2013 |
| Received | May 23, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131494
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.