The following data is part of a premarket notification filed by J.m. Sounds Electronics Co. with the FDA for Peritoneal Dialysis Cycler Model Pdc1000.
| Device ID | K791676 |
| 510k Number | K791676 |
| Device Name: | PERITONEAL DIALYSIS CYCLER MODEL PDC1000 |
| Classification | System, Dialysate Delivery, Semi-automatic, Peritoneal |
| Applicant | J.M. SOUNDS ELECTRONICS CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KPF |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-08-27 |
| Decision Date | 1979-12-06 |