The following data is part of a premarket notification filed by Biotronik Sales, Inc. with the FDA for Kalos-04 Pulse Generator.
| Device ID | K844841 |
| 510k Number | K844841 |
| Device Name: | KALOS-04 PULSE GENERATOR |
| Classification | Implantable Pacemaker Pulse-generator |
| Applicant | BIOTRONIK SALES, INC. POST OFFICE BOX 1988 Lake Oswego, OR 97034 |
| Contact | Cawthon |
| Correspondent | Cawthon BIOTRONIK SALES, INC. POST OFFICE BOX 1988 Lake Oswego, OR 97034 |
| Product Code | DXY |
| CFR Regulation Number | 870.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-12 |
| Decision Date | 1985-04-18 |