510(k) K180481
K180481 is an FDA 510(k) premarket notification submitted by S.A.L.F. Spa for the device "Servator B SALF Solution". The FDA issued a decision of Substantially Equivalent on June 29, 2018. The device falls under product code KDN (System, Perfusion, Kidney), a Class II device regulated under 21 CFR 876.5880. S.A.L.F. Spa has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 29, 2018
- Date Received
- February 23, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Perfusion, Kidney
- Device Class
- Class II
- Regulation Number
- 876.5880
- Review Panel
- GU
- Submission Type