The following data is part of a premarket notification filed by Biotronik Sales, Inc. with the FDA for Kalos-03.
| Device ID | K812218 |
| 510k Number | K812218 |
| Device Name: | KALOS-03 |
| Classification | Implantable Pacemaker Pulse-generator |
| Applicant | BIOTRONIK SALES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DXY |
| CFR Regulation Number | 870.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-08-06 |
| Decision Date | 1981-10-13 |