ARTIS ZEE AND ZEEGO

System, X-ray, Angiographic

SIEMENS MEDICAL SOLUTIONS USA, INC.

The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Artis Zee And Zeego.

Pre-market Notification Details

Device IDK073290
510k NumberK073290
Device Name:ARTIS ZEE AND ZEEGO
ClassificationSystem, X-ray, Angiographic
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. MS E-50 Malvern,  PA  19355
ContactGary Johnson
CorrespondentGary Johnson
SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. MS E-50 Malvern,  PA  19355
Product CodeIZI  
CFR Regulation Number892.1600 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-11-21
Decision Date2008-02-11
Summary:summary

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