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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K032145
Device Name AUDICOR UPGRADE SYSTEM
Applicant
Inovise Medical, Inc.
1025 Industrial Pkwy.
Suite C
Newberg,  OR  97132
Applicant Contact STEVE HESLER
Correspondent
Inovise Medical, Inc.
1025 Industrial Pkwy.
Suite C
Newberg,  OR  97132
Correspondent Contact STEVE HESLER
Regulation Number870.2340
Classification Product Code
DPS  
Date Received07/14/2003
Decision Date 10/31/2003
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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