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510(k) K243985

Rio™ Drug Reconstitution Transfer Device by Icu Medical, Inc. — Product Code LHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 2025
Date Received
December 23, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Set, I.V. Fluid Transfer
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

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