ARTIS ZEE AND ZEEGO


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

Correspodent Contact gary johnson
Regulation Number 892.1600
Classification Product Code
IZI  
Date Received 11/21/2007
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