510(k) K170095
K170095 is an FDA 510(k) premarket notification submitted by Medimop Medical Project , Ltd. for the device "Vial2Bag Direct Connect". The FDA issued a decision of Substantially Equivalent on Mar 8, 2017. The device falls under product code LHI (Set, I.V. Fluid Transfer), a Class II device regulated under 21 CFR 880.5440. Medimop Medical Project , Ltd. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 8, 2017
- Date Received
- Jan 11, 2017
- Clearance Type
- Special
- 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)