510(k) K240748
K240748 is an FDA 510(k) premarket notification submitted by Sfm Medical Devices GmbH for the device "nextaro® v, 20/20". The FDA issued a decision of Substantially Equivalent on April 16, 2024. The device falls under product code LHI (Set, I.V. Fluid Transfer), a Class II device regulated under 21 CFR 880.5440. Sfm Medical Devices GmbH has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 16, 2024
- Date Received
- March 19, 2024
- 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