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U.S. Department of Health and Human Services

510(k) Premarket Notification
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ProductCode: DSI Applicant: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES Decision Date To: 05/22/2024
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carescape one and carescape dock f0, model numbers mbz323 and mfa101, carescape ecg, model number mke101,carescape temp, model number mkt101, carescape pres, model number mkp101, carescape spo2, model numbers mks101 and mks201 GE Medical Systems Information Technologies, Inc. K213234 04/12/2022
monitor b105m, monitor b125m, monitor b155m, monitor b105p, monitor b125p GE Medical Systems Information Technologies, Inc. K213490 04/01/2022
monitor b125, monitor b105 GE Medical Systems Information Technologies, Inc. K201941 11/04/2020
capnostat / capnoflex co2 system GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES K083750 03/23/2009
modification to cic pro clinical information center GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES K062976 03/16/2007
cic pro clinical information center central station GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES K032370 08/13/2003
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