The following data is part of a premarket notification filed by Pacesetter Systems with the FDA for Programalith Programmer.
| Device ID | K823242 |
| 510k Number | K823242 |
| Device Name: | PROGRAMALITH PROGRAMMER |
| Classification | Monitor, Ultrasonic, Fetal |
| Applicant | PACESETTER SYSTEMS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KNG |
| CFR Regulation Number | 884.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-11-01 |
| Decision Date | 1983-01-08 |