UNITY NETWORK ID

Monitor, Physiological, Patient (without 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 Unity Network Id.

Pre-market Notification Details

Device IDK051518
510k NumberK051518
Device Name:UNITY NETWORK ID
ClassificationMonitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Applicant GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 8200 WEST TOWER AVE. Milwaukee,  WI  53223
ContactRonald N Blaski
CorrespondentRonald N Blaski
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 8200 WEST TOWER AVE. Milwaukee,  WI  53223
Product CodeMWI  
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-06-08
Decision Date2005-07-08
Summary:summary

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