Cleared Traditional

ALARIS SYSTEM WITH GUARDRAILS SUITE MX

K133532 · Carefusion 303, Inc. · General Hospital
Aug 2014
Decision
276d
Days
Class 2
Risk

About This 510(k) Submission

K133532 is an FDA 510(k) clearance for the ALARIS SYSTEM WITH GUARDRAILS SUITE MX, 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 August 21, 2014, 276 days after receiving the submission on November 18, 2013. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K133532 FDA.gov
FDA Decision Cleared SESE
Date Received November 18, 2013
Decision Date August 21, 2014
Days to Decision 276 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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