510(k) K100565 ยท MKJ Automated External Defibrillators (Non-Wearable)
DURA PADZ (REUSABLE ELECTRODE), DURA PADZ GEL (DISPOSABLE HYDROGEL) MODEL 8900-0300, 8900-0325
| Applicant | Bio-Detek, Inc., Pawtucket RI, US |
| Decision | Substantially Equivalent, Nov 16, 2010 |
| Received | Mar 1, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100565
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.