UNITY NETWORK ID

Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC

The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies, Inc with the FDA for Unity Network Id.

Pre-market Notification Details

Device IDK103432
510k NumberK103432
Device Name:UNITY NETWORK ID
ClassificationMonitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Applicant GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC 8200 WEST TOWER AVENUE Milwaukee,  WI  53223
ContactRobert Casarsa
CorrespondentRobert Casarsa
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC 8200 WEST TOWER AVENUE Milwaukee,  WI  53223
Product CodeMWI  
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-11-23
Decision Date2010-12-17
Summary:summary

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