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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 10 of 33 Results
ProductCode: MHX Applicant: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES Decision Date To: 05/09/2024
 
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portrait vsm GE Medical Systems Information Technologies, Inc. K233810 04/25/2024
mural clinical viewer GE Medical Systems Information Technologies, Inc. K222586 12/21/2022
ek12 v2 algorithm GE Medical Systems Information Technologies, Inc. K221904 12/20/2022
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
ek12 algorithm GE Medical Systems Information Technologies, Inc. K170155 06/06/2017
12sl ecg analysis program GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. K141963 02/05/2015
12sl ecg analysis program GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES K092369 02/24/2010
carescape monitor b850 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES K092027 08/28/2009
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