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510(k) K203434

BlueStar Rx by Welldoc, Inc. — Product Code NDC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 2021
Date Received
November 23, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calculator, Drug Dose
Device Class
Class II
Regulation Number
868.1890
Review Panel
CH
Submission Type

Other clearances by Welldoc, Inc.

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  • K190013 — WellDoc BlueStar (November 4, 2019)
  • K162532 — WellDoc BlueStar, WellDoc BlueStar Rx (January 12, 2017)
  • K162225 — WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System (November 22, 2016)
  • K141273 — WELLDOC DIABETESMANAGER SYSTEM AND DIABETESMANAGER- RX SYSTE (July 8, 2014)
  • K120314 — WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM (February 24, 2012)
  • K112370 — WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM (October 14, 2011)
  • K100066 — DIABETESMANAGER SYSTEM, DIABETESMANAGER-RX SYSTEM MODEL VERSION 1.1 (July 15, 2010)

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