The following data is part of a premarket notification filed by Pace Medical with the FDA for Model 4220.
| Device ID | K913134 |
| 510k Number | K913134 |
| Device Name: | MODEL 4220 |
| Classification | Implantable Pacemaker Pulse-generator |
| Applicant | PACE MEDICAL 391 TOTTEN POND RD. Waltham, MA 02451 |
| Contact | Robert C.mace |
| Correspondent | Robert C.mace PACE MEDICAL 391 TOTTEN POND RD. Waltham, MA 02451 |
| Product Code | DXY |
| CFR Regulation Number | 870.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-16 |
| Decision Date | 1991-08-22 |