Cleared Traditional

PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0 MODULE FOR PLUM A+ INFUSION SYSTEM UPGRADE

K141789 · Hospira, Inc. · General Hospital
Jan 2015
Decision
198d
Days
Class 2
Risk

About This 510(k) Submission

K141789 is an FDA 510(k) clearance for the PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0 MODULE FOR PLUM A+ INFUSION SYSTEM UPGRADE, a Pump, Infusion (Class II — Special Controls, product code FRN), submitted by Hospira, Inc. (Lake Forest, US). The FDA issued a Cleared decision on January 16, 2015, 198 days after receiving the submission on July 2, 2014. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K141789 FDA.gov
FDA Decision Cleared SESE
Date Received July 02, 2014
Decision Date January 16, 2015
Days to Decision 198 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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