The following data is part of a premarket notification filed by Pacesetter Systems with the FDA for Electrode, Pacemaker, Permanent.
| Device ID | K810139 |
| 510k Number | K810139 |
| Device Name: | ELECTRODE, PACEMAKER, PERMANENT |
| Classification | Permanent Pacemaker Electrode |
| Applicant | PACESETTER SYSTEMS 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-01-21 |
| Decision Date | 1981-11-27 |