510(k) K162216
K162216 is an FDA 510(k) premarket notification submitted by Laboratorios Grifols, S.A. for the device "GRI-FILL PERISTALTIC SET". The FDA issued a decision of Substantially Equivalent on Oct 19, 2017. The device falls under product code LHI (Set, I.V. Fluid Transfer), a Class II device regulated under 21 CFR 880.5440. Laboratorios Grifols, S.A. has 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 19, 2017
- Date Received
- Aug 8, 2016
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Set, I.V. Fluid Transfer
- Device Class
- Class II
- Regulation Number
- 880.5440
- Review Panel
- HO
- Submission Type
- 510(k)