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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Infusion Safety Management Software
510(k) Number K242117
Device Name LifeShield Infusion Safety Software Suite
Applicant
Icu Medical, Inc.
600 N. Field Dr.
Lake Forest,  IL  60045
Applicant Contact Pernell Abrantes
Correspondent
Icu Medical, Inc.
600 N. Field Dr.
Lake Forest,  IL  60045
Correspondent Contact Pernell Abrantes
Regulation Number880.5725
Classification Product Code
PHC  
Date Received07/19/2024
Decision Date 04/02/2025
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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