510(k) K040489
K040489 is an FDA 510(k) premarket notification submitted by Chf Solutions, Inc. for the device "AQUADEX SYSTEM 100, MODEL A1100". The FDA issued a decision of Substantially Equivalent on April 27, 2004. The device falls under product code KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System), a Class II device regulated under 21 CFR 876.5860. Chf Solutions, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 27, 2004
- Date Received
- February 26, 2004
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Device Class
- Class II
- Regulation Number
- 876.5860
- Review Panel
- GU
- Submission Type