GE DISCOVERY ST

System, Tomography, Computed, Emission

GE HEALTHCARE

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

Pre-market Notification Details

Device IDK041543
510k NumberK041543
Device Name:GE DISCOVERY ST
ClassificationSystem, Tomography, Computed, Emission
Applicant GE HEALTHCARE 3000 N. GRANDVIEW BLVD Waukesha,  WI  53188
ContactLarry A Kroger
CorrespondentTamas Borsai
TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton,  CT  06470
Product CodeKPS  
CFR Regulation Number892.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2004-06-08
Decision Date2004-06-22
Summary:summary

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