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510(k) K212530

IVX Fluid Transfer Set by Omnicell, Inc. — Product Code LHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2022
Date Received
August 11, 2021
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

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