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510(k) K220695

Elite Biomedical Solutions Dose Request Cord by Elite Biomedical Solutions — Product Code MRZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2022
Date Received
March 9, 2022
Clearance Type
Traditional
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 for product code MRZ

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  • K201634 — RG 3ml Medication Cartridge (March 26, 2021)
  • 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)
  • K162225 — WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System (November 22, 2016)