510(k) K960329 ยท MKJ Automated External Defibrillators (Non-Wearable)
DISPOSABLE HYDROGEL DEFIBRILLATION ELECTRODE/PAD
| Applicant | Contour Medical Technology, Inc., Lavergne TN, US |
| Decision | Substantially Equivalent, Jul 2, 1996 |
| Received | Jan 24, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K960329
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 2, 2015 | Covidien LLC Physio-Control QuikCombo Pacing/Defibrillation/ECG Electrodes RediPak Preconnect System
Item Code:PM20022 Terminated |
MKJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.