|
|
|
Device Name
|
|
|
|
|
Company
|
|
|
|
|
Date
Approved |
|
|
Device or Consumer
Information/Instructions |
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
|
FREESTYLE LIBRE PRO FLASH GLUCOSE MONITORING SYSTEM
supplements available
|
Abbott Diabetes Care Inc. |
Sep 23, 2016 |
P150021 Approval Order
Summary of Safety & Effectiveness
Labeling
|
MINIMED 630G SYSTEM WITH SMARTGUARD(TM)
supplements available
|
MEDTRONIC MINIMED |
Aug 10, 2016 |
P150001 Approval Order
Summary of Safety & Effectiveness
Labeling
|
IPRO2 CGM SYSTEM WITH ENLITE SENSOR
supplements available
|
MEDTRONIC MINIMED |
Jun 17, 2016 |
P150029 Approval Order
Summary of Safety & Effectiveness
Labeling
|
