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FDA 510(k)

SpaceStation MRI

K-Number: K191910 · 2020-03-12

ApplicantB. Braun Melsugen AG
Decision Date2020-03-12
Product CodeMRZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SpaceStation MRI is a medical device manufactured by B. Braun Melsugen AG. It received FDA 510(k) clearance on 2020-03-12 under approval 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. It is manufactured by B. Braun Melsugen AG. The 510(k) number is K191910.

When was SpaceStation MRI approved by the FDA?

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

What company makes SpaceStation MRI?

SpaceStation MRI is manufactured by B. Braun Melsugen AG.

What is the FDA product code for SpaceStation MRI?

The FDA product code for SpaceStation MRI is MRZ.

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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.

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