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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name System, X-Ray, Angiographic
510(k) Number K073290
Device Name ARTIS ZEE AND ZEEGO
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
51 VALLEY STREAM PKWY.
MS E-50
MALVERN,  PA  19355
Applicant Contact GARY JOHNSON
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
51 VALLEY STREAM PKWY.
MS E-50
MALVERN,  PA  19355
Correspondent Contact GARY JOHNSON
Regulation Number892.1600
Classification Product Code
IZI  
Date Received11/21/2007
Decision Date 02/11/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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