510(k) K021366 ยท DQK Computer, Diagnostic, Programmable
MAC-LAB/CARDIOLAB EP/COMBOLAB
| Applicant | General Electric Medical Systems Information Techn, Milwaukee WI, US |
| Decision | Substantially Equivalent, Jul 3, 2002 |
| Received | Apr 30, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K021366
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 25, 2003 | General Electric Medical Systems Information Technology MAC-LAB 1000EX systems Terminated |
KMI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.