The following data is part of a premarket notification filed by Pace Medical with the FDA for Model Ev4543 Miniature Temporary Cardiac Pacemaker.
| Device ID | K870323 |
| 510k Number | K870323 |
| Device Name: | MODEL EV4543 MINIATURE TEMPORARY CARDIAC PACEMAKER |
| Classification | Pulse-generator, Pacemaker, External |
| Applicant | PACE MEDICAL 391 TOTTEN POND RD. Waltham, MA 02451 |
| Contact | Ralph E Hanson |
| Correspondent | Ralph E Hanson 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 | 1987-01-28 |
| Decision Date | 1987-03-03 |