The following data is part of a premarket notification filed by Zcv ,inc. with the FDA for Zynergy Zolution Electrophysiology Catheter, Model Z50000.
| Device ID | K991060 |
| 510k Number | K991060 |
| Device Name: | ZYNERGY ZOLUTION ELECTROPHYSIOLOGY CATHETER, MODEL Z50000 |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | ZCV ,INC. 298 FERNWOOD AVE. Edison, NJ 08837 |
| Contact | Priscilla Whitehead Cox |
| Correspondent | Priscilla Whitehead Cox ZCV ,INC. 298 FERNWOOD AVE. Edison, NJ 08837 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-30 |
| Decision Date | 2000-04-06 |
| Summary: | summary |