The following data is part of a premarket notification filed by Dialysis Systems, Inc. with the FDA for Bicard Mixing System.
| Device ID | K030366 |
| 510k Number | K030366 |
| Device Name: | BICARD MIXING SYSTEM |
| Classification | Tank, Holding, Dialysis |
| Applicant | DIALYSIS SYSTEMS, INC. 2003 BLAIR BLVD. Nashville, TN 37212 |
| Contact | Mark Vesligaj |
| Correspondent | Mark Vesligaj DIALYSIS SYSTEMS, INC. 2003 BLAIR BLVD. Nashville, TN 37212 |
| Product Code | FIN |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-04 |
| Decision Date | 2004-04-19 |
| Summary: | summary |