The following data is part of a premarket notification filed by Vitatron Medical Bv with the FDA for Ceryx6, 611, Ceryx 3 311 & Ceryx 1 111.
| Device ID | K844485 |
| 510k Number | K844485 |
| Device Name: | CERYX6, 611, CERYX 3 311 & CERYX 1 111 |
| Classification | Programmer, Pacemaker |
| Applicant | VITATRON MEDICAL BV P.O. BOX 76 6950 AB Dieren, NL |
| Contact | Renirie |
| Correspondent | Renirie VITATRON MEDICAL BV P.O. BOX 76 6950 AB Dieren, NL |
| Product Code | KRG |
| CFR Regulation Number | 870.3700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-19 |
| Decision Date | 1985-04-19 |