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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
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