510(k) K150055 ยท MKJ Automated External Defibrillators (Non-Wearable)
OneStep Pediatric CPR Multi-Function Electrode
| Applicant | Bio-Detek, Inc., Pawtucket RI, US |
| Decision | Substantially Equivalent, May 2, 2015 |
| Received | Jan 12, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150055
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.