The following data is part of a premarket notification filed by Vitatron Medical Bv with the FDA for Ceryx Pacemaker Models 114, 314 & 614.
| Device ID | K854790 |
| 510k Number | K854790 |
| Device Name: | CERYX PACEMAKER MODELS 114, 314 & 614 |
| Classification | Implantable Pacemaker Pulse-generator |
| Applicant | VITATRON MEDICAL BV 6470 RIVERVIEW TERRACE N.E. Minneapolis, MN 55432 |
| Contact | Constance G Bundy |
| Correspondent | Constance G Bundy VITATRON MEDICAL BV 6470 RIVERVIEW TERRACE N.E. Minneapolis, MN 55432 |
| Product Code | DXY |
| CFR Regulation Number | 870.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-29 |
| Decision Date | 1986-08-28 |