FDA 510(k)

SpaceStation MRI

K-Number: K191910 · 2020-03-12

Decision Date2020-03-12

Product CodeMRZ

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

SpaceStation MRI is the device name listed in this FDA 510(k) record. The listed applicant is B. Braun Melsugen AG. It received FDA 510(k) clearance on 2020-03-12 under 510(k) number K191910. The device is classified under product code MRZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SpaceStation MRI?

SpaceStation MRI is a medical device that received FDA 510(k) clearance on 2020-03-12. The listed applicant is B. Braun Melsugen AG. The 510(k) number is K191910.

When did SpaceStation MRI receive FDA 510(k) clearance?

SpaceStation MRI received FDA 510(k) clearance on 2020-03-12, under 510(k) number K191910.

Who is the listed applicant for SpaceStation MRI?

The FDA 510(k) record lists B. Braun Melsugen AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SpaceStation MRI?

The FDA product code for SpaceStation MRI is MRZ.

Related Devices (Code: MRZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230718UTC 3mL Medication CartridgeGilero, LLC K220695Elite Biomedical Solutions Dose Request CordElite Biomedical Solutions K201634RG 3ml Medication CartridgeChengdu Shifeng Medical Technology Co., Ltd.K193654BlueStar RxWelldoc, Inc.K190013WellDoc BlueStarWelldoc, Inc.K173531Lockbox for Perfusor Space PCA Infusion PumpB.Braun Medical, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.