510(k) K191093
K191093 is an FDA 510(k) premarket notification submitted by Isopure, Corp. for the device "Isopure Dry Acid Dissolution System". The FDA issued a decision of Substantially Equivalent on Jan 22, 2020. The device falls under product code KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder)), a Class II device regulated under 21 CFR 876.5820. Isopure, Corp. has 4 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 22, 2020
- Date Received
- Apr 25, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type
- 510(k)