Cleared Traditional

Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module

K161469 · Hospira, Inc. · General Hospital
Mar 2017
Decision
305d
Days
Class 2
Risk

About This 510(k) Submission

K161469 is an FDA 510(k) clearance for the Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module, a Pump, Infusion (Class II — Special Controls, product code FRN), submitted by Hospira, Inc. (Lake Forest, US). The FDA issued a Cleared decision on March 28, 2017, 305 days after receiving the submission on May 27, 2016. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K161469 FDA.gov
FDA Decision Cleared SESE
Date Received May 27, 2016
Decision Date March 28, 2017
Days to Decision 305 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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