The following data is part of a premarket notification filed by Ash Medical Systems, Inc. with the FDA for Biologic 1000 Hemodialysis Mach/hd-1000 Disp Cartr.
| Device ID | K864179 |
| 510k Number | K864179 |
| Device Name: | BIOLOGIC 1000 HEMODIALYSIS MACH/HD-1000 DISP CARTR |
| Classification | System, Dialysate Delivery, Sorbent Regenerated |
| Applicant | ASH MEDICAL SYSTEMS, INC. 2701 B KENT AVE. West Lafayette, IN 47906 |
| Contact | Stephen R Ash |
| Correspondent | Stephen R Ash ASH MEDICAL SYSTEMS, INC. 2701 B KENT AVE. West Lafayette, IN 47906 |
| Product Code | FKT |
| CFR Regulation Number | 876.5600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-24 |
| Decision Date | 1986-12-11 |