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Device Name
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Company
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|
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Date Approved |
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Device or Consumer Information/Instructions |
Dexcom G6 Pro Continuous Glucose Monitoring System
|
Dexcom, Inc. |
Oct 07, 2019 |
K191833
|
Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System and Dexcom Pro Q Continuous Glucose Monitoring System
|
Dexcom, Inc. |
Jun 28, 2019 |
K191450
|
Dexcom G6 Continuous Glucose Monitoring System
|
Dexcom, Inc. |
Feb 14, 2019 |
K183206
|
Dexcom Pro Q Continuous Glucose Monitoring System
|
Dexcom, Inc. |
Nov 02, 2018 |
K182405
|
Dexcom G6 Glucose Program Continuous Glucose Monitoring System
|
Dexcom, Inc. |
Oct 26, 2018 |
K182041
|
EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM
supplements available
|
Senseonics, Incorporated |
Jun 21, 2018 |
P160048 Approval Order Summary of Safety & Effectiveness Labeling
|
t:slim X2 Insulin Pump with Basal-IQ Technology
supplements available
|
Tandem Diabetes Care, Inc. |
Jun 21, 2018 |
P180008 Approval Order Summary of Safety & Effectiveness Labeling
|
Guardian Connect system
supplements available
|
Medtronic Minimed |
Mar 08, 2018 |
P160007 Approval Order Summary of Safety & Effectiveness Labeling
|
Freestyle Libre Flash Glucose Monitoring System
supplements available
|
Abbott Diabetes Care, Inc. |
Sep 27, 2017 |
P160030 Approval Order Summary of Safety & Effectiveness Labeling
|
MiniMed 670G System
supplements available
|
Medtronic Minimed, Inc. |
Sep 28, 2016 |
P160017 Approval Order Summary of Safety & Effectiveness Labeling
|
|