Cleared Traditional

ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTION

K110535 · Carefusion 303, Inc. · General Hospital
Mar 2012
Decision
395d
Days
Class 2
Risk

About This 510(k) Submission

K110535 is an FDA 510(k) clearance for the ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTION, a Pump, Infusion (Class II — Special Controls, product code FRN), submitted by Carefusion 303, Inc. (San Diego, US). The FDA issued a Cleared decision on March 26, 2012, 395 days after receiving the submission on February 25, 2011. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K110535 FDA.gov
FDA Decision Cleared SESE
Date Received February 25, 2011
Decision Date March 26, 2012
Days to Decision 395 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FRN — Pump, Infusion
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5725

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