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510(k) K051253

Device
MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR LV (WITH AND WITHOUT PCM)
Applicant
BAXTER HEALTHCARE CORP.
510(k) number
K051253
Product code
MEA  
Decision
Substantially Equivalent (SESE)
Decision date
2005-07-15
Date received
2005-05-16
Regulation
880.5725
Classification name
Pump, Infusion, Pca
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
NANETTE HEDDEN
Address
1620 Waukegan Rd. Mcgaw Park IL US 60085 60085

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MEA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K162165ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent PumpSummit Medical Products, Inc.2017-08-29
K170982CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Administrator Medication Safety Software; CADD® Administration Sets; Wireless Communication Module (CM)Smiths Medical Ads, Inc.2017-08-24
K143612LifeCare PCA Infusion SystemHospira, Inc.2016-04-08
K130394CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0Smiths Medical Asd, Inc.2013-12-09
K092313PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEMB.Braun Medical, Inc.2009-11-04
K072144CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE - ADMINISTRATORSmiths Medical MD, Inc.2008-03-07
K043299MEDLEY PCA MODULE, MODEL 8120Alaris Medical Systems, Inc.2004-12-10
K043256HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07; LIFECARE PCA INFUSION SYSTEM STERILE EMPY VIALS, MODEL 6021-04-03Hospira, Inc.2004-12-06
K042800LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWAREHospira, Inc.2004-10-18
K033054HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMPHarvard Clinical Technology2003-12-16
K032233MEDLEY PCA MODULE, MODEL 8120Alaris Medical Systems, Inc.2003-09-09
K031566SYNDEO PCA SYRINGE PUMP, MODEL 2L3113Baxter Healthcare Corp2003-08-19
K030661STRYKER PAINPUMP2Stryker Instruments2003-05-30
K020418GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICESP.T. Greenleaf2003-04-29
K020421GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICESHennig Enterprises Europe Srl2003-04-29

Legacy Summary#

summary

FDA Review#

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