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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 10 of 27 Results
ProductCode: DQK Applicant: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES Decision Date To: 05/10/2024
 
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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
case v7.0 cardiac testing system and cardiosoft v7.0 cardiac testing system GE Medical Systems Information Technologies, Inc. K231870 12/13/2023
graffiti GE Medical Systems Information Technologies, Inc. K202189 12/08/2020
mac 5 a4/ mac 5 a5/ mac 5 lite resting ecg analysis system GE Medical Systems Information Technologies, Inc. K221321 10/18/2022
mac 7 - resting ecg analysis system GE Medical Systems Information Technologies, Inc. K203786 04/30/2021
mac vu360 resting ecg analysis system GE Medical Systems Information Technologies, Inc. K173830 09/18/2018
mac-lab hemodynamic recording system; cardiolab electrophysiology recording system; combolab hemodynamic and electrophys GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. K130626 05/01/2013
mars holter analysis workstation GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. K132437 12/04/2013
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
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