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Welldoc, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
11
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K222888BlueStar CGM insulin dose calculatorAugust 11, 2023
K230813BlueStar and BlueStar RxJuly 28, 2023
K203434BlueStar RxSeptember 8, 2021
K193654BlueStar RxApril 7, 2020
K190013WellDoc BlueStarNovember 4, 2019
K162532WellDoc BlueStar, WellDoc BlueStar RxJanuary 12, 2017
K162225WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx SystemNovember 22, 2016
K141273WELLDOC DIABETESMANAGER SYSTEM AND DIABETESMANAGER- RX SYSTEJuly 8, 2014
K120314WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEMFebruary 24, 2012
K112370WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEMOctober 14, 2011
K100066DIABETESMANAGER SYSTEM, DIABETESMANAGER-RX SYSTEM MODEL VERSION 1.1July 15, 2010