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510(k) K990312

Device
AVIA PAIN MEDICATION DELIVERY SYSTEM
Applicant
AMTEC MEDICAL
510(k) number
K990312
Product code
MEA  
Decision
Substantially Equivalent (SESE)
Decision date
1999-04-22
Date received
1999-02-01
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
Statement
Third party reviewed
No

Applicant Contact#

Contact
TERRELL L FRIEDRICH
Address
9119 Metric Blvd. Austin TX US 78758 78758

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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
K051253MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR LV (WITH AND WITHOUT PCM)Baxter Healthcare Corp2005-07-15
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

Legacy Summary#

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FDA Review#

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