510(k) K162887
K162887 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corporation for the device "PrismaSATE". The FDA issued a decision of Substantially Equivalent on Jan 6, 2017. The device falls under product code KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder)), a Class II device regulated under 21 CFR 876.5820. Baxter Healthcare Corporation has 60 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 6, 2017
- Date Received
- Oct 17, 2016
- Clearance Type
- Special
- 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)