510(k) K081371 ยท MKJ Automated External Defibrillators (Non-Wearable)
SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GEL
| Applicant | Leonhard Lang GmbH, Stillwater MN, US |
| Decision | Substantially Equivalent, Sep 24, 2008 |
| Received | May 15, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081371
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 19, 2014 | Leonhard Lang Gmbh GE Healthcare Pediatric Direct-Wired Disposable Defibrillation/Pacing Electrodes. REF 2059144-001 and 2059144-005. .
Product Usage: Usage:
Skintact Pediatric Multifunction Electrodes are for use o Terminated |
MKJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.