510(k) K102194
K102194 is an FDA 510(k) premarket notification submitted by B. Braun Avitum AG for the device "SOLCART B". The FDA issued a decision of Substantially Equivalent on Apr 25, 2011. The device falls under product code KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder)), a Class II device regulated under 21 CFR 876.5820. B. Braun Avitum AG has 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 25, 2011
- Date Received
- Aug 4, 2010
- 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)