510(k) K011847 ยท DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
ZYNERGY Z5000 ELECTROPHYSIOLOGY CATHETER WITH Z9000 ACCESSORY CABLE
| Applicant | Zynergy Cardio Vasular (Zcv), Inc., Edison NJ, US |
| Decision | Substantially Equivalent, Jul 13, 2001 |
| Received | Jun 13, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K011847
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.