510(k) K150966
K150966 is an FDA 510(k) premarket notification submitted by Haemopharm Biofluids S.R.L. for the device "HMB32". The FDA issued a decision of Substantially Equivalent on December 4, 2015. The device falls under product code KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder)), a Class II device regulated under 21 CFR 876.5820. Haemopharm Biofluids S.R.L. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 4, 2015
- Date Received
- April 13, 2015
- 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