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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, Tomography, Computed
510(k) Number K023687
Device Name SOMATOM EMOTION 6 CT SYSTEMS
Applicant
SIEMENS MEDICAL SYSTEMS, INC.
186 WOOD AVENUE SOUTH
ISELIN,  NJ  08830
Applicant Contact PRAVEEN NADKARNI
Correspondent
SIEMENS MEDICAL SYSTEMS, INC.
186 WOOD AVENUE SOUTH
ISELIN,  NJ  08830
Correspondent Contact PRAVEEN NADKARNI
Regulation Number892.1750
Classification Product Code
JAK  
Date Received11/01/2002
Decision Date 11/22/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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