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510(k) K112370

WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM by Welldoc, Inc. — Product Code MRZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 2011
Date Received
August 17, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

Other clearances by Welldoc, Inc.

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  • 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)
  • K100066 — DIABETESMANAGER SYSTEM, DIABETESMANAGER-RX SYSTEM MODEL VERSION 1.1 (July 15, 2010)

Other clearances for product code MRZ

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  • K193654 — BlueStar Rx (April 7, 2020)
  • K191910 — SpaceStation MRI (March 12, 2020)
  • K190013 — WellDoc BlueStar (November 4, 2019)
  • K173531 — Lockbox for Perfusor Space PCA Infusion Pump (August 2, 2018)
  • K171346 — Sapphire Sets (August 25, 2017)
  • K162532 — WellDoc BlueStar, WellDoc BlueStar Rx (January 12, 2017)
  • K160492 — Hospira Sapphire Sets (December 6, 2016)