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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph, Ambulatory, With Analysis Algorithm
510(k) Number K110569
Device Name AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR)
Applicant
INOVISE MEDICAL, INC.
8770 SW NIMBUS AVENUE
SUITE D
BEAVERTON,  OR  97008 -7196
Applicant Contact EARL ANDERSON
Correspondent
INOVISE MEDICAL, INC.
8770 SW NIMBUS AVENUE
SUITE D
BEAVERTON,  OR  97008 -7196
Correspondent Contact EARL ANDERSON
Regulation Number870.2800
Classification Product Code
MLO  
Date Received02/28/2011
Decision Date 10/24/2011
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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