The following data is part of a premarket notification filed by American Medical Products, Inc. with the FDA for Cyler/heater For Peritoneal Dialysis.
| Device ID | K791584 |
| 510k Number | K791584 |
| Device Name: | CYLER/HEATER FOR PERITONEAL DIALYSIS |
| Classification | System, Dialysate Delivery, Semi-automatic, Peritoneal |
| Applicant | AMERICAN MEDICAL PRODUCTS, INC. 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 | 1979-08-17 |
| Decision Date | 1979-11-16 |