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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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mars holter analysis workstation GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES K051026 07/19/2005
mars holter analysis workstation GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES K093141 12/29/2009
mars holter analysis workstation GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. K132437 12/04/2013
mac-lab/cardiolab ep/combolab system GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES K050093 05/13/2005
mac-lab hemodynamic recording system; cardiolab electrophysiology recording system; combolab hemodynamic and electrophys GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. K130626 05/01/2013
mac vu360 resting ecg analysis system GE Medical Systems Information Technologies, Inc. K173830 09/18/2018
mac 7 - resting ecg analysis system GE Medical Systems Information Technologies, Inc. K203786 04/30/2021
mac 5500 hd, mac 3500 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC K110266 04/29/2011
mac 1600 ecg analysis system GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES K081437 07/15/2008
heart-exercise GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES GMBH K091594 07/29/2009
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