FDA 510(k) Applications for Medical Device Product Code "MEA"
(Pump, Infusion, Pca)

FDA 510(k) Number Applicant Device Name Decision Date
K022203 ABBOTT LABORATORIES ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384 08/01/2002
K032233 ALARIS MEDICAL SYSTEMS, INC. MEDLEY PCA MODULE, MODEL 8120 09/09/2003
K043299 ALARIS MEDICAL SYSTEMS, INC. MEDLEY PCA MODULE, MODEL 8120 12/10/2004
K990312 AMTEC MEDICAL AVIA PAIN MEDICATION DELIVERY SYSTEM 04/22/1999
K092313 B. BRAUN MEDICAL, INC. PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM 11/04/2009
K002739 BAXTER HEALTHCARE CORP. INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K 09/11/2000
K051253 BAXTER HEALTHCARE CORP. MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR LV (WITH AND WITHOUT PCM) 07/15/2005
K031566 BAXTER HEALTHCARE CORP. SYNDEO PCA SYRINGE PUMP, MODEL 2L3113 08/19/2003
K013822 CANE SRL MICROJET CRONO PCA 05/08/2002
K033054 HARVARD CLINICAL TECHNOLOGY HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP 12/16/2003
K020421 HENNIG ENTERPRISES EUROPE S.R.L. GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES 04/29/2003
K143612 Hospira, Inc LifeCare PCA Infusion System 04/08/2016
K043256 HOSPIRA, INC. HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07; LIFECARE PCA INFUSION SYSTEM STERILE EMPY VIALS, MODEL 6021-04-03 12/06/2004
K042800 HOSPIRA, INC. LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE 10/18/2004
K020418 P.T. GREENLEAF GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES 04/29/2003
K982839 SIMS DELTEC, INC. CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300 11/02/1998
K170982 Smiths Medical ADS, Inc. CADD«- 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) 08/24/2017
K130394 SMITHS MEDICAL ASD, INC. CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0 12/09/2013
K072144 SMITHS MEDICAL MD, INC. CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE - ADMINISTRATOR 03/07/2008
K002434 SORENSON MEDICAL, INC. PALM PUMP 08/23/2000
K030661 STRYKER INSTRUMENTS STRYKER PAINPUMP2 05/30/2003
K162165 SUMMIT MEDICAL PRODUCTS, INC ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump 08/29/2017


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