The following data is part of a premarket notification filed by Siemens Elema Ab with the FDA for Pulse Generator 689, 689b & 689l.
| Device ID | K841225 |
| 510k Number | K841225 |
| Device Name: | PULSE GENERATOR 689, 689B & 689L |
| Classification | Implantable Pacemaker Pulse-generator |
| Applicant | SIEMENS ELEMA AB BURDITT, BOWLES & RADZIUS 135 SOUTH LASALLE STREET Chicago , IL 60603 - |
| Contact | Joseph R Radzius |
| Correspondent | Joseph R Radzius SIEMENS ELEMA AB BURDITT, BOWLES & RADZIUS 135 SOUTH LASALLE STREET Chicago , IL 60603 - |
| Product Code | DXY |
| CFR Regulation Number | 870.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-03-22 |
| Decision Date | 1984-12-03 |