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FDA 510(k) Applications for Medical Device Product Code "PHC"
FDA 510(k) Number
Applicant
Device Name
Decision Date
K211124
Baxter Healthcare Corporation
Dose IQ Safety Software
08/30/2022
K141474
BECTON DICKINSON & CO.
BECTON DICKINSON INTELLIPORT SYSTEM
12/18/2014
K182092
Becton, Dickinson, and Company
BD Intelliport System
04/30/2019
K210075
Fresenius Kabi AG
Vigilant Software Suite û Vigilant Master Med
03/01/2022
K223606
ICU Medical, Inc.
LifeShieldÖ Infusion Safety Software Suite
08/24/2023
K141193
SMITHS MEDICAL ASD, INC.
MEDFUSION 4000 PUMP DEVICE SPECIFIC REPORTS SOLFWARE FOR PHARMGUARD SERVER VERSION 2.0
07/25/2014
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