GE DISCOVERY ST SYSTEM

System, Tomography, Computed, Emission

GE MEDICAL SYSTEMS

The following data is part of a premarket notification filed by Ge Medical Systems with the FDA for Ge Discovery St System.

Pre-market Notification Details

Device IDK041220
510k NumberK041220
Device Name:GE DISCOVERY ST SYSTEM
ClassificationSystem, Tomography, Computed, Emission
Applicant GE MEDICAL SYSTEMS P.O. 414 Milwaukee,  WI  53188
ContactDavid Duersteler
CorrespondentDavid Duersteler
GE MEDICAL SYSTEMS P.O. 414 Milwaukee,  WI  53188
Product CodeKPS  
CFR Regulation Number892.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-05-10
Decision Date2004-06-15
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.