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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Warmer, Thermal, Infusion Fluid
510(k) Number K211618
Device Name Fluido Compact Blood and Fluid Warming System
Applicant
The Surgical Company International B.V.
Beeldschermweg 6f
Amersfoort,  NL 3821 AH
Applicant Contact Inette Nieveen
Correspondent
The Surgical Company International B.V.
Beeldschermweg 6f
Amersfoort,  NL 3821 AH
Correspondent Contact Inette Nieveen
Regulation Number880.5725
Classification Product Code
LGZ  
Date Received05/26/2021
Decision Date 06/05/2023
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
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