The following data is part of a premarket notification filed by Edwards Pacemaker Systems with the FDA for Edwards Pacemaker 30 Unipolar Generator.
| Device ID | K791751 |
| 510k Number | K791751 |
| Device Name: | EDWARDS PACEMAKER 30 UNIPOLAR GENERATOR |
| Classification | Implantable Pacemaker Pulse-generator |
| Applicant | EDWARDS PACEMAKER SYSTEMS 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 | 1979-09-05 |
| Decision Date | 1979-09-26 |