The following data is part of a premarket notification filed by Cp Medical with the FDA for Rs-1000.
| Device ID | K911230 |
| 510k Number | K911230 |
| Device Name: | RS-1000 |
| Classification | Accessories, Blood Circuit, Hemodialysis |
| Applicant | CP MEDICAL P.O. BOX 5668 Huntington Beach, CA 92615 |
| Contact | Carl Grodach |
| Correspondent | Carl Grodach CP MEDICAL P.O. BOX 5668 Huntington Beach, CA 92615 |
| Product Code | KOC |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-20 |
| Decision Date | 1993-06-09 |