510(k) K943698 ยท MKJ Automated External Defibrillators (Non-Wearable)
STAT PADZ STERILE ADULT MULTI-FUNCTION ELECTRODES
| Applicant | Zoll Medical Corp, Burlington MA, US |
| Decision | Substantially Equivalent, Dec 28, 1994 |
| Received | Jul 29, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K943698
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 9, 2014 | Bio-Detek, Inc. ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE)
Part Number: 8900-4012
Product Usage:
These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable Terminated |
MKJ | None listed |
| Oct 9, 2014 | Bio-Detek, Inc. ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Single.
Part number: 8900-4013
Product Usage:
These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disp Terminated |
MKJ | None listed |
| Oct 9, 2014 | Bio-Detek, Inc. ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires
Part number: 8900-4052
Product Usage:
These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult Terminated |
MKJ | None listed |
| Oct 9, 2014 | Bio-Detek, Inc. ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires, 1 single
Part number:
8900-4055-40
Product Usage:
These MFE Electrodes are used in connection with ZOLL Defibrillat Terminated |
MKJ | None listed |
| Sep 17, 2014 | Bio-Detek, Inc. ZOLL Pro-padz Sterile Adult Multi-Function Electrodes
Part number: 8900-4012
These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's Terminated |
MKJ | None listed |
| Sep 17, 2014 | Bio-Detek, Inc. ZOLL Pro-padz Sterile Adult Multi-Function Electrodes
((singles)
Part number: 8900-4013
These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable sing Terminated |
MKJ | None listed |
| Sep 17, 2014 | Bio-Detek, Inc. ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with
10-ft (3 m) leadwires
Part number: 8900-4052
These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These d Terminated |
MKJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.