510(k) K072430 ยท MKJ Automated External Defibrillators (Non-Wearable)
ZOLL PEDIPADZ REDUCED ENERGY ELECTRODE
| Applicant | ZOLL Medical Corporation, Chelsmford MA, US |
| Decision | Substantially Equivalent, Nov 6, 2007 |
| Received | Aug 29, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072430
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 13, 2012 | Bio-Detek, Inc. Zoll pedi.padz Reduced Energy Multi-Function Electrodes (MFE)
Part number: 8900-0401
Used in connection with Zoll M Series and E series Defibrillators specifically for pediatric patients. Terminated |
None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.