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510(k) K191910

SpaceStation MRI by B. Braun Melsugen AG — Product Code MRZ

K191910 is an FDA 510(k) premarket notification submitted by B. Braun Melsugen AG for the device "SpaceStation MRI". The FDA issued a decision of Substantially Equivalent on March 12, 2020. The device falls under product code MRZ (Accessories, Pump, Infusion), a Class II device regulated under 21 CFR 880.5725.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 2020
Date Received
July 17, 2019
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

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  • K201634 — RG 3ml Medication Cartridge (March 26, 2021)
  • K193654 — BlueStar Rx (April 7, 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)

FDA data resources