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U.S. Department of Health and Human Services

510(k) Premarket Notification

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21 to 30 of 33 Results
ProductCode: MHX Applicant: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES Decision Date To: 05/09/2024
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aware transport monitor system (includes aware pod and aware transport monitor) GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES K042642 11/03/2004
modification to dash 3000/4000 patient monitor GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES K040458 06/03/2004
solar 9500 information monitor GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES K033964 01/15/2004
modification to mac 5000 ecg analysis system GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES K033492 11/24/2003
modification to dash 3000/4000 patient monitor GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES K033304 11/12/2003
apexpro fh telemetry system GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES K033365 11/06/2003
modification to: apexpro telemetry system GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES K032369 08/15/2003
dinamap pro 1000 v3 monitor, model 1100 series GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES K031376 07/16/2003
dinamap pro 1000 monitor with superstat, model 1000 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES K022834 05/13/2003
ek-pro arrhythmia detection algorithm GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES K031320 05/06/2003
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