510(k) K023080 ยท DTE Pulse-Generator, Pacemaker, External
GALIX PACESTAR
| Applicant | Galix Biomedical Instrumentation, Inc., Miami Beach FL, US |
| Decision | Substantially Equivalent, Jun 11, 2003 |
| Received | Sep 17, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K023080
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.