The following data is part of a premarket notification filed by Chf Solutions, Inc. with the FDA for Aquadex System 100, Model A1100.
| Device ID | K040489 |
| 510k Number | K040489 |
| Device Name: | AQUADEX SYSTEM 100, MODEL A1100 |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | CHF SOLUTIONS, INC. SUITE 170-7601 NORTHLAND DR. Brooklyn Park, MN 55428 |
| Contact | Amy Peterson |
| Correspondent | Amy Peterson CHF SOLUTIONS, INC. SUITE 170-7601 NORTHLAND DR. Brooklyn Park, MN 55428 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-26 |
| Decision Date | 2004-04-27 |
| Summary: | summary |