510(k) K240748

nextaro® v, 20/20 by Sfm Medical Devices GmbH — Product Code LHI

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