The following data is part of a premarket notification filed by Usfilter with the FDA for Usfilter Bicarbonate Mixing And Dispensing (bicarb) System.
| Device ID | K031502 |
| 510k Number | K031502 |
| Device Name: | USFILTER BICARBONATE MIXING AND DISPENSING (BICARB) SYSTEM |
| Classification | Tank, Holding, Dialysis |
| Applicant | USFILTER 725 WOOTEN RD. Colorado Springs, CO 80915 |
| Contact | Edward L Armstrong |
| Correspondent | Edward L Armstrong USFILTER 725 WOOTEN RD. Colorado Springs, CO 80915 |
| Product Code | FIN |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-13 |
| Decision Date | 2004-08-27 |
| Summary: | summary |