510(k) K142803 ยท MKJ Automated External Defibrillators (Non-Wearable)
Skintact, various other tradenames
| Applicant | Leonhard Lang GmbH, Innsbruck, AT |
| Decision | Substantially Equivalent, Dec 2, 2014 |
| Received | Sep 29, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142803
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 12, 2017 | Leonhard Lang Medizintechnik GmbH Skintact Electrode for Defibrillation, Pacing, Monitoring, Cardioversion.
Product Usage:
Multifunction electrode for external defibrillation, pacing, cardioversion, and monitoring. The device is n Terminated |
MKJ | None listed |
| Oct 14, 2016 | Leonhard Lang Medizintechnik GmbH Skintact Electrodes for Defibrillation, DF29N.
Product Usage:
Multifunction electrode for external defibrillation, pacing, cardioversion, and monitoring. The device is non-sterile and for single use Terminated |
MKJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.