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
K230665 Baxter Healthcare Corporation Dose IQ Safety Software 03/29/2024
K243062 Becton Dickinson BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229); BD Intelliport Gateway (516232); BD Intelliport Mount (516233); BD Intelliport Charger (516231) 06/20/2025
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
K242117 ICU Medical, Inc. LifeShield Infusion Safety Software Suite 04/02/2025
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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