The following data is part of a premarket notification filed by Pace Medical with the FDA for Miniature Models 4562/4563/4572/4573 Pacemaker.
| Device ID | K913805 |
| 510k Number | K913805 |
| Device Name: | MINIATURE MODELS 4562/4563/4572/4573 PACEMAKER |
| 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 | 1991-08-26 |
| Decision Date | 1991-11-19 |