510(k) K001305 ยท DQK Computer, Diagnostic, Programmable
MAC-LAB SYSTEM AND CARDIOLAB EP SYSTEM
| Applicant | General Electric Medical Systems Information Techn, Sugarland TX, US |
| Decision | Substantially Equivalent, Jun 27, 2000 |
| Received | Apr 24, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001305
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.