The following data is part of a premarket notification filed by Pacesetter Systems with the FDA for Implantable Pacemaker Pulse Gen, Models 241 & 242.
| Device ID | K823878 |
| 510k Number | K823878 |
| Device Name: | IMPLANTABLE PACEMAKER PULSE GEN, MODELS 241 & 242 |
| Classification | Implantable Pacemaker Pulse-generator |
| Applicant | PACESETTER SYSTEMS 12884 BRADLEY AVE. Sylmar, CA 91342 |
| Contact | Diana Upp |
| Correspondent | Diana Upp PACESETTER SYSTEMS 12884 BRADLEY AVE. Sylmar, CA 91342 |
| Product Code | DXY |
| CFR Regulation Number | 870.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-12-27 |
| Decision Date | 1983-03-24 |