MODIFICATION TO GE DISCOVERY LS 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 Modification To Ge Discovery Ls System.

Pre-market Notification Details

Device IDK040172
510k NumberK040172
Device Name:MODIFICATION TO GE DISCOVERY LS SYSTEM
ClassificationSystem, Tomography, Computed, Emission
Applicant GE MEDICAL SYSTEMS P.O. BOX 414 Milwaukee,  WI  53201
ContactLarry A Kroger
CorrespondentLarry A Kroger
GE MEDICAL SYSTEMS P.O. BOX 414 Milwaukee,  WI  53201
Product CodeKPS  
CFR Regulation Number892.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-01-26
Decision Date2004-04-07
Summary:summary

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