Cleared Traditional

SpaceStation MRI

K191910 · B. Braun Melsugen AG · General Hospital

Mar 2020

Decision

239d

Days

Class 2

Risk

About This 510(k) Submission

K191910 is an FDA 510(k) clearance for the SpaceStation MRI, a Accessories, Pump, Infusion (Class II — Special Controls, product code MRZ), submitted by B. Braun Melsugen AG (Melsungen, DE). The FDA issued a Cleared decision on March 12, 2020, 239 days after receiving the submission on July 17, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number	K191910 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 17, 2019
Decision Date	March 12, 2020
Days to Decision	239 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF