510(k) K020984 ยท MKJ Automated External Defibrillators (Non-Wearable)
ACCESSAED, SEMI-AUTOMATIC EXTERNAL DEFIBRILLATORS
| Applicant | Access Cardiosystems, Inc., Concord MA, US |
| Decision | Substantially Equivalent - Subject to Tracking Reg., Aug 14, 2002 |
| Received | Mar 18, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K020984
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 20, 2004 | Access CardioSystems AccessAED (without audio record)
Model Number: 9100-0100-0 Terminated |
MKJ | None listed |
| Jul 20, 2004 | Access CardioSystems Access AED and Access ALS Automated External Defibrillators
Model No. : 9100-0100 Terminated |
MKJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.