SYNGO CIRCULATION

System, X-ray, Tomography, Computed

SIEMENS AG, MEDICAL SOLUTIONS

The following data is part of a premarket notification filed by Siemens Ag, Medical Solutions with the FDA for Syngo Circulation.

Pre-market Notification Details

Device IDK052029
510k NumberK052029
Device Name:SYNGO CIRCULATION
ClassificationSystem, X-ray, Tomography, Computed
Applicant SIEMENS AG, MEDICAL SOLUTIONS SIEMENSSTRASSE 1 Forchheim,  DE D 91301
ContactRuediger Koerner
CorrespondentStefan Preiss
TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton,  MN  55112 -1891
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2005-07-27
Decision Date2005-08-09
Summary:summary

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