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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K051907
Device Name INNOCOR
Applicant
Innovision A/S
70 W. Madison St., Suite 3300
Chicago,  IL  60602
Applicant Contact RICHARD O WOOD
Correspondent
Innovision A/S
70 W. Madison St., Suite 3300
Chicago,  IL  60602
Correspondent Contact RICHARD O WOOD
Regulation Number870.1425
Classification Product Code
DQK  
Date Received07/14/2005
Decision Date 03/02/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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