510(k) K133441 ยท MKJ Automated External Defibrillators (Non-Wearable)
ONESTEP CPR II MULTI-FUNCTION ELECTRODE
| Applicant | Bio-Detek, Inc., Chelsmford MA, US |
| Decision | Substantially Equivalent, Oct 10, 2014 |
| Received | Nov 12, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133441
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.