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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 25 Results
ProductCode: DQK Applicant: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES Decision Date To: 05/20/2022
 
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capnostat / capnoflex co2 system GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES K083750 03/23/2009
cardiosoft/case cardiac testing system GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES K031561 08/01/2003
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 cardiac testing system, cs cardiac testing system GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES GMBH K103678 02/16/2011
graffiti GE Medical Systems Information Technologies, Inc. K202189 12/08/2020
heart-exercise GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES GMBH K091594 07/29/2009
mac 1600 ecg analysis system GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES K081437 07/15/2008
mac 5500 hd, mac 3500 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC K110266 04/29/2011
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
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