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510(k) K141789

Device
PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0 MODULE FOR PLUM A+ INFUSION SYSTEM UPGRADE
Applicant
HOSPIRA, INC.
510(k) number
K141789
Product code
FRN  
Decision
Substantially Equivalent (SESE)
Decision date
2015-01-16
Date received
2014-07-02
Regulation
880.5725
Classification name
Pump, Infusion
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Yuliya Matlin
Address
275 N. Field Dr. Lake Forest IL US 60045 60045

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FRN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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K242115Plum Duo™ Precision IV PumpIcu Medical, Inc.2025-04-02
K242114Plum Solo™ Precision IV PumpIcu Medical, Inc.2025-04-02
K250357RemunityPRO™ Pump for Remodulin® (treprostinil) InjectionDeka Research & Development Corp.2025-03-11
K241736Remunity 2.0 Pump for Remodulin (treprostinil) InjectionDeka Research and Development Corp.2025-01-16
K242735Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 750 ml/min)Belmont Medical Technologies2024-12-23
K242660Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration SetsZevex, Inc.2024-10-03
K242390Novum IQ Syringe Pump (40800BAXUS)Baxter Healthcare Corporation2024-09-05
K232793Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-Series Adminstration SetsZevex, Inc.2024-05-17
K211122Novum IQ Large Volume PumpBaxter Healthcare Corporation2024-03-29
K231918Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe AdapterKoru Medical Systems2023-11-03

Legacy Summary#

summary

FDA Review#

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