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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 Ave.
Suite D
Beaverton,  OR  97008 -7196
Applicant Contact EARL ANDERSON
Correspondent
Inovise Medical, Inc.
8770 SW Nimbus Ave.
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
Predetermined Change
Control Plan Authorized		 No
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