510(k) K232875
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 14, 2023
- Date Received
- September 15, 2023
- Clearance Type
- Traditional
- 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