The following data is part of a premarket notification filed by Siemens Elema Ab with the FDA for Siemens-elema Pulse Generator 668.
| Device ID | K801324 |
| 510k Number | K801324 |
| Device Name: | SIEMENS-ELEMA PULSE GENERATOR 668 |
| Classification | Implantable Pacemaker Pulse-generator |
| Applicant | SIEMENS ELEMA AB 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DXY |
| CFR Regulation Number | 870.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-06-03 |
| Decision Date | 1980-12-01 |