MODIFICATION TO DASH 3000/4000 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 3000/4000 Patient Monitor.

Pre-market Notification Details

Device IDK033304
510k NumberK033304
Device Name:MODIFICATION TO DASH 3000/4000 PATIENT MONITOR
ClassificationMonitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Applicant GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 8200 WEST TOWER AVE. Milwaukee,  WI  53223
ContactMelissa Robinson
CorrespondentMelissa Robinson
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 8200 WEST TOWER AVE. Milwaukee,  WI  53223
Product CodeMHX  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-10-14
Decision Date2003-11-12
Summary:summary

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