The following data is part of a premarket notification filed by Pace Medical with the FDA for Model 4800 Accupace Pacing System Analyer.
| Device ID | K925143 |
| 510k Number | K925143 |
| Device Name: | MODEL 4800 ACCUPACE PACING SYSTEM ANALYER |
| Classification | Pulse-generator, Pacemaker, External |
| 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 | DTE |
| CFR Regulation Number | 870.3600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-13 |
| Decision Date | 1994-09-27 |