MODIFICATION TO DASH 2500 PATIENT MONITOR

Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES

The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for Modification To Dash 2500 Patient Monitor.

Pre-market Notification Details

Device IDK090702
510k NumberK090702
Device Name:MODIFICATION TO DASH 2500 PATIENT MONITOR
ClassificationMonitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Applicant GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 8200 WEST TOWER AVE. Milwaukee,  WI  53223
ContactDavid Wahlig
CorrespondentDavid Wahlig
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 8200 WEST TOWER AVE. Milwaukee,  WI  53223
Product CodeMHX  
Subsequent Product CodeDPS
Subsequent Product CodeDQA
Subsequent Product CodeDXN
Subsequent Product CodeFFL
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-03-17
Decision Date2009-04-15
Summary:summary

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