510(k) K970391 ยท MKJ Automated External Defibrillators (Non-Wearable)
QUANTUM EDGE PEDIATRIC DEFIRBRILLATION ELECTRODES
| Applicant | Contour Medical Technology, Inc., Lavergne TN, US |
| Decision | Substantially Equivalent, Mar 6, 1997 |
| Received | Feb 3, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970391
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.