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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Couch, Radiation Therapy, Powered
510(k) Number K072898
Device Name HEXAPOD EVO RT COUCH TOP
Applicant
MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH
ROBERT-BOSCH-STRASSE 8
SCHWABMUNCHEN,  DE 86830
Applicant Contact MICHAEL WOLFF
Correspondent
TUV SUD AMERICA INC.
1775 OLD HIGHWAY 8 NW
NEW BRIGHTON,  MN  55112 -1891
Correspondent Contact STEFAN PREISS
Regulation Number892.5770
Classification Product Code
JAI  
Date Received10/11/2007
Decision Date 10/25/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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