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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
Recalls CDRH Recalls
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