The following data is part of a premarket notification filed by Siemens Elema Ab with the FDA for Pacemaker Patient Mgmt. System.
| Device ID | K801810 |
| 510k Number | K801810 |
| Device Name: | PACEMAKER PATIENT MGMT. SYSTEM |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | SIEMENS ELEMA AB 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-07-30 |
| Decision Date | 1981-02-05 |