The following data is part of a premarket notification filed by Amicon, Inc. with the FDA for Amicon Equaline Fluid Balance System.
| Device ID | K875121 |
| 510k Number | K875121 |
| Device Name: | AMICON EQUALINE FLUID BALANCE SYSTEM |
| Classification | System, Dialysate Delivery, Semi-automatic, Peritoneal |
| Applicant | AMICON, INC. 17 CHERRY HILL DR. Danvers, MA 01923 |
| Contact | James M Delaney |
| Correspondent | James M Delaney AMICON, INC. 17 CHERRY HILL DR. Danvers, MA 01923 |
| Product Code | KPF |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-15 |
| Decision Date | 1988-02-19 |