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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Pump, Infusion
510(k) Number K191910
Device Name SpaceStation MRI
Applicant
B. Braun Melsugen AG
Carl-Braun-Strasse 1
Melsungen,  DE 34212
Applicant Contact Ullrich Trottier
Correspondent
Emergo Global Consulting , LLC
2500 Bee Cave Road
Austin,  TX  78746
Correspondent Contact Andre Kindsvater
Regulation Number880.5725
Classification Product Code
MRZ  
Subsequent Product Code
FRN  
Date Received07/17/2019
Decision Date 03/12/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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