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510(k) Data Aggregation
K Number
K110535Device Name
ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTION
Manufacturer
Date Cleared
2012-03-26
(395 days)
Product Code
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
CAREFUSION 303,INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Alaris® PC Unit is the main user interface unit and power supply of the Alaris® System, a modular system to be used with Alaris® System modules (aka Medley™ System modules) intended for use in today's growing professional healthcare environment for facilities that utilize infusion and/or monitoring devices. The specific intended use for each Alaris® System module is specified in its respective submission.
Device Description
The Alaris System is a modular system that consists of a point-of-care unit (PC unit) that provides the main user interface and power supply for the associated infusion and monitoring modules. This update is only for the Alaris PC unit Module 8000 software correction and does not require any change to the associated modules, systems, or accessories of the Alaris System. The basic functionality and existing features as described in the original and subsequent 510(k) submissions for the Alaris System and associated modules will not change.
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