FDA.reportPublic FDA data

510(k) K162165

Device
AmbIT PCA*PIB, AmbIT PIB, AmbIT PIB*PCA, AmbIT PIEB, And AmbIT Programmable Intermittent Pump
Applicant
SUMMIT MEDICAL PRODUCTS, INC
510(k) number
K162165
Product code
MEA  
Decision
Substantially Equivalent (SESE)
Decision date
2017-08-29
Date received
2016-08-03
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
LeVoy Haight
Address
504 W. 8360 S. Sandy UT US 84070 84070

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
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
K020421GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICESHennig Enterprises Europe Srl2003-04-29

Legacy Summary#

summary

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases