The following data is part of a premarket notification filed by Alan P. Kendal, Ph.d. with the FDA for Portadial Carry-on Kidney Machine.
| Device ID | K802297 |
| 510k Number | K802297 |
| Device Name: | PORTADIAL CARRY-ON KIDNEY MACHINE |
| Classification | System, Dialysate Delivery, Central Multiple Patient |
| Applicant | ALAN P. KENDAL, PH.D. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FKQ |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-09-19 |
| Decision Date | 1981-05-01 |