The following data is part of a premarket notification filed by Renal Systems, Inc. with the FDA for Hemasite Access Monitor (tent.) #rs-8200.
| Device ID | K811977 |
| 510k Number | K811977 |
| Device Name: | HEMASITE ACCESS MONITOR (TENT.) #RS-8200 |
| Classification | Accessories, Blood Circuit, Hemodialysis |
| Applicant | RENAL SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KOC |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-07-13 |
| Decision Date | 1981-07-31 |