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LZG — Pump, Infusion, Insulin Class II

FDA Device Classification

Classification Details

Product Code
LZG
Device Class
Class II
Regulation Number
880.5725
Submission Type
Review Panel
CH
Medical Specialty
General Hospital
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
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K192659insulet corporationOmnipod Insulin Management System, Omnipod DASH Insulin Management SystemOctober 21, 2019
K182630insulet corporationOmnipod Insulin Management System, Omnipod DASH Insulin Management SystemJanuary 8, 2019
K180045insulet corporationOmnipod DASH Insulin Management SystemJune 1, 2018
K162296insulet corporationOmniPod Insulin Management SystemApril 18, 2017
K162080tandem diabetes caret:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device UpOctober 25, 2016
K160056tandem diabetes caret:slim Insulin Delivery SystemJuly 25, 2016
K160482tandem diabetes caret:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device UpJuly 13, 2016
K160252insulet corporationOmniPod Insulin Management SystemApril 27, 2016
K143189tandem diabetes caret:flex Insulin Delivery SystemJanuary 9, 2015
K142619asante solutionsSnap Insulin Pump SystemDecember 18, 2014
K140439insulet corporationOMNIPOD INSULIN MANAGEMENT SYSTEMNovember 13, 2014
K141758tandem diabetes careT:SLIM INSULIN DELIVERY SYSTEMOctober 31, 2014
K133593tandem diabetes careT:SLIM INSULIN DELIVERY SYSTEMMarch 24, 2014
K131294insulet corporationOMNIPOD INSULIN MANAGEMENT SYSTEMAugust 29, 2013
K122483asante solutionsPEARL DIABETES MANAGEMENT SYSTEMJanuary 3, 2013