510(k) K113787 ยท MKJ Automated External Defibrillators (Non-Wearable)
DDU-120 FULLY AUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES
| Applicant | Defibtech, LLC, Guilford CT, US |
| Decision | Substantially Equivalent, Jan 4, 2013 |
| Received | Dec 22, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113787
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.