ADVANTAGE WINDOWS 3D OPTION AND DENTASCAN OPTION

System, X-ray, Tomography, Computed

GE MEDICAL SYSTEMS

The following data is part of a premarket notification filed by Ge Medical Systems with the FDA for Advantage Windows 3d Option And Dentascan Option.

Pre-market Notification Details

Device IDK923077
510k NumberK923077
Device Name:ADVANTAGE WINDOWS 3D OPTION AND DENTASCAN OPTION
ClassificationSystem, X-ray, Tomography, Computed
Applicant GE MEDICAL SYSTEMS PO BOX 414 Milwaukee,  WI  53201
ContactLarry A Kroger
CorrespondentLarry A Kroger
GE MEDICAL SYSTEMS PO BOX 414 Milwaukee,  WI  53201
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-06-25
Decision Date1993-02-02

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