The following data is part of a premarket notification filed by Trimedyne, Inc. with the FDA for Chematic Bicarbonate Dialysate System.
| Device ID | K810605 |
| 510k Number | K810605 |
| Device Name: | CHEMATIC BICARBONATE DIALYSATE SYSTEM |
| Classification | Subsystem, Proportioning |
| Applicant | TRIMEDYNE, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FKR |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-03-06 |
| Decision Date | 1981-06-16 |