IVX Fluid Transfer Set

Set, I.v. Fluid Transfer

Omnicell, Inc.

The following data is part of a premarket notification filed by Omnicell, Inc. with the FDA for Ivx Fluid Transfer Set.

Pre-market Notification Details

Device IDK212530
510k NumberK212530
Device Name:IVX Fluid Transfer Set
ClassificationSet, I.v. Fluid Transfer
Applicant Omnicell, Inc. 500 Cranberry Woods Drive Cranberry,  PA  16066
ContactDavid Vanella
CorrespondentDavid Vanella
Omnicell, Inc. 500 Cranberry Woods Drive Cranberry,  PA  16066
Product CodeLHI  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-11
Decision Date2022-04-24

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