510(k) K072233 ยท MKJ Automated External Defibrillators (Non-Wearable)
SKINTACT MULTIFUNCTIONAL ELECTRODES WITH DH02 GEL WITH DIFFERENT CONNECTORS COMPATIBLE WITH DIFFERENT DEFIBRILLATORS
| Applicant | Leonhard Lang GmbH, Stillwater MN, US |
| Decision | Substantially Equivalent, Oct 5, 2007 |
| Received | Aug 10, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K072233
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 24, 2009 | Leonhard Lang Gmbh SKINTACT Electrodes for Defibrillation, 10X REF DF20, Rx only, Manufactured by Leonhard Lang GmbH, Archenweg 56, 6020 Innsbruck, Austria.
The device is non-sterile and single use.
For use on adults Terminated |
MKJ | None listed |
| Sep 24, 2009 | Leonhard Lang Gmbh S&W Electrodes for Defibrillation, 10 Defibrillation Electrodes, Reorder #90101, S & W Healthcare Corp, 1525 Flight Path Drive Brooksville, Florida 34604
The device is non-sterile and single use.
F Terminated |
MKJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.