PLUM A+ HYPERBARIC INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE

Pump, Infusion

HOSPIRA, INC.

The following data is part of a premarket notification filed by Hospira, Inc. with the FDA for Plum A+ Hyperbaric Infusion System With Hospira Mednet Software.

Pre-market Notification Details

Device IDK081412
510k NumberK081412
Device Name:PLUM A+ HYPERBARIC INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
ClassificationPump, Infusion
Applicant HOSPIRA, INC. 275 NORTH FIELD DR. D-389, BLDG., H2 Lake Forest,  IL  60045
ContactDaniela Weksler
CorrespondentNed Devine
UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook,  IL  60062
Product CodeFRN  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2008-05-20
Decision Date2008-12-17
Summary:summary

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