510(k) K033771 ยท MKJ Automated External Defibrillators (Non-Wearable)
BIO-DETEK MODIFIED ADULT MULTI-FUNCTION ELECTRODE WITH CONNECTOR
| Applicant | Bio-Detek, Inc., Pawtucket RI, US |
| Decision | Substantially Equivalent, Feb 27, 2004 |
| Received | Dec 3, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033771
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 2, 2014 | Bio-Detek, Inc. Medsolutions4U Multi-Function Electrodes to be used with PhysioControl Lifepak Defibrillators, models 9, 10C, 11, 12, 15, 20, 500 and are indicated for Defibrillation, Cardioversion, Pacing, and Monit Terminated |
MKJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.