The following data is part of a premarket notification filed by American Medical Products, Inc. with the FDA for Cycler W/5 Or 10 Hr. Fill/dwell Timer.
| Device ID | K800496 |
| 510k Number | K800496 |
| Device Name: | CYCLER W/5 OR 10 HR. FILL/DWELL TIMER |
| 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 | 1980-03-04 |
| Decision Date | 1980-07-21 |