The following data is part of a premarket notification filed by Chf Solutions, Inc. with the FDA for System 100; S-100 Ultrafiltration Console; Bdt 500 Ultrafiltration Set.
| Device ID | K013733 |
| 510k Number | K013733 |
| Device Name: | SYSTEM 100; S-100 ULTRAFILTRATION CONSOLE; BDT 500 ULTRAFILTRATION SET |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | CHF SOLUTIONS, INC. 1730 PENNSYLVANIA AVE., N.W. Washington, DC 20006 |
| Contact | Dianna Thomsen |
| Correspondent | Dianna Thomsen CHF SOLUTIONS, INC. 1730 PENNSYLVANIA AVE., N.W. Washington, DC 20006 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-09 |
| Decision Date | 2002-06-03 |
| Summary: | summary |