510(k) K051076 ยท MKJ Automated External Defibrillators (Non-Wearable)
ZOLL STAT*PADZ MWP MULTI-FUNCTION ELECTRODES
| Applicant | ZOLL Medical Corporation, Chelsmford MA, US |
| Decision | Substantially Equivalent, May 13, 2005 |
| Received | Apr 27, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K051076
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 20, 2008 | Bio-Detek, Inc. ZOLL OneStep Multi-Function Electrode; Adult Complete
Part #: 8900-0214-01. The electrodes are indicated for the following clinical applications: Defibrillation, Cardioversion, Noninvasive pacing, an Terminated |
MLN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.