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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, I.V. Fluid Transfer
510(k) Number K243985
Device Name Rio™ Drug Reconstitution Transfer Device
Applicant
Icu Medical, Inc.
951 Calle Amanecer
San Clemente,  CA  92673
Applicant Contact Michelle Doherty
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number880.5440
Classification Product Code
LHI  
Date Received12/23/2024
Decision Date 01/22/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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