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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 23 Results
ProductCode: DQK Applicant: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES Decision Date To: 09/22/2021
 
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mac 7 - resting ecg analysis system GE Medical Systems Information Technologies, Inc. K203786 04/30/2021
graffiti GE Medical Systems Information Technologies, Inc. K202189 12/08/2020
monitor b125, monitor b105 GE Medical Systems Information Technologies, Inc. K201941 11/04/2020
mac vu360 resting ecg analysis system GE Medical Systems Information Technologies, Inc. K173830 09/18/2018
muse cardiology information system GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. K152993 01/12/2016
mars holter analysis workstation GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. K132437 12/04/2013
mac-lab hemodynamic recording system; cardiolab electrophysiology recording system; combolab hemodynamic and electrophys GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. K130626 05/01/2013
muse cardiology information system GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. K130155 03/01/2013
muse cardiology information system GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. K110132 05/25/2011
mac 5500 hd, mac 3500 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC K110266 04/29/2011
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