510(k) K010214 ยท MKJ Automated External Defibrillators (Non-Wearable)
FIRSTSAVE BIPHASIC MODEL #9200 AND 9210
| Applicant | Survivalink Corp., Minnetonka MN, US |
| Decision | Substantially Equivalent, Feb 22, 2001 |
| Received | Jan 23, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K010214
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 17, 2008 | Cardiac Science Corporation Electrode Adaptor Cable Quick-Combo System, Model 9055
The 9055 Electrode Adaptor is intended for use by trained personnel who use a Cardiac Science Automated External Defibrillator (AED) for defibril Terminated |
MKJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.