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510(k) K141273

WELLDOC DIABETESMANAGER SYSTEM AND DIABETESMANAGER- RX SYSTE by Welldoc, Inc. — Product Code MRZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 2014
Date Received
May 16, 2014
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

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

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  • 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)