510(k) K895916 ยท DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
PE INTERCARDIAC MAPPING SYSTEM (ICMS)
| Applicant | Prucka Engineering, Inc., Bellaire TX, US |
| Decision | Substantially Equivalent, Dec 13, 1989 |
| Received | Oct 10, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K895916
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.