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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 K182092
Device Name BD Intelliport System
Applicant
Becton, Dickinson and Company
1 Becton Dr.
Franklin Lakes,  NJ  07417
Applicant Contact Rahul Ram
Correspondent
Becton, Dickinson and Company
1 Becton Dr.
Franklin Lakes,  NJ  07417
Correspondent Contact Rahul Ram
Regulation Number880.5725
Classification Product Code
PHC  
Subsequent Product Code
FPA  
Date Received08/03/2018
Decision Date 04/30/2019
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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