Cleared Traditional

PLUM A+ HYPERBARIC INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE

K081412 · Hospira, Inc. · General Hospital
Dec 2008
Decision
211d
Days
Class 2
Risk

About This 510(k) Submission

K081412 is an FDA 510(k) clearance for the PLUM A+ HYPERBARIC INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE, a Pump, Infusion (Class II — Special Controls, product code FRN), submitted by Hospira, Inc. (Lake Forest, US). The FDA issued a Cleared decision on December 17, 2008, 211 days after receiving the submission on May 20, 2008. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K081412 FDA.gov
FDA Decision Cleared SESE
Date Received May 20, 2008
Decision Date December 17, 2008
Days to Decision 211 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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