510(k) K082861 ยท MKJ Automated External Defibrillators (Non-Wearable)
AMCO REPLACEMENT BATTERY FOR POWERHEART AED, NON-RECHARGEABLE, MODEL 2L561; G3, NON-RECHARGABLE, MODEL 7L561
| Applicant | Amco International Manufacturing & Design, Inc., Elizabeth CO, US |
| Decision | Substantially Equivalent, Nov 25, 2008 |
| Received | Sep 29, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082861
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.