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U.S. Department of Health and Human Services

510(k) Premarket Notification

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11 to 20 of 25 Results
ProductCode: DQK Applicant: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES Decision Date To: 05/20/2022
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heart-exercise GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES GMBH K091594 07/29/2009
mars holter analysis workstation GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES K093141 12/29/2009
case cardiac testing system, cs cardiac testing system GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES GMBH K103678 02/16/2011
mac 5500 hd, mac 3500 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC K110266 04/29/2011
muse cardiology information system GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. K110132 05/25/2011
muse cardiology information system GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. K130155 03/01/2013
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
muse cardiology information system GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. K152993 01/12/2016
mac vu360 resting ecg analysis system GE Medical Systems Information Technologies, Inc. K173830 09/18/2018
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