510(k) K193005
K193005 is an FDA 510(k) premarket notification submitted by Dialco Medical, Inc. for the device "DIMI RRT System". The FDA issued a decision of Substantially Equivalent on Aug 28, 2020. 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.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 28, 2020
- Date Received
- Oct 28, 2019
- Clearance Type
- Traditional
- 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
- 510(k)