510(k) K954395 ยท DQK Computer, Diagnostic, Programmable
CARTO SYSTEM
| Applicant | Biosense, Ltd., Tirat Hacarmel, IL |
| Decision | Substantially Equivalent, Dec 21, 1995 |
| Received | Sep 20, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954395
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.