510(k) K022732 ยท MKJ Automated External Defibrillators (Non-Wearable)
INFANT/CHILD REDUCED ENERGY ELECTRODES
| Applicant | Medtronic Physio-Control Corp., Redmond WA, US |
| Decision | Substantially Equivalent, Dec 13, 2002 |
| Received | Aug 16, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K022732
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 24, 2020 | Physio-Control, Inc. Infant/Child Reduced Energy Defibrillation Electrodes, Part Number: 3202380-006, for use with LIFEPAK 1000 defibrillator, LIFEPAK 500 defibrillator, and LIFEPAK CR Plus/EXPRESS defibrillator - Product Terminated |
MKJ | None listed |
| Apr 24, 2020 | Physio-Control, Inc. Infant Child Starter Kits, Part Number: 3202784-009, containing Infant/Child Reduced Energy Defibrillation Electrodes, for use with LIFEPAK 1000 defibrillator, LIFEPAK 500 defibrillator, and LIFEPAK Terminated |
MKJ | None listed |
| Dec 12, 2017 | Physio-Control, Inc. LIFEPAK(R) defibrillation electrodes, Catalog # 11101-000016, MIN #3202380-006
The defibrillation electrodes are used only with LIFEPAK EXPRESS(R) AED, LIFEPAK CR(R) Plus AED, LIFEPAK 1000 defibrill Terminated |
MKJ | None listed |
| Dec 12, 2017 | Physio-Control, Inc. LIFEPAK(R) Electrode Starter Kits, Catalog # 11101-000017, MIN #3202784-009
The defibrillation electrodes are used only with LIFEPAK EXPRESS(R) AED, LIFEPAK CR(R) Plus AED, LIFEPAK 1000 defibrillato Terminated |
MKJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.