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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 K130660
Device Name AUDICOR CPAM WITH SDB (SINGLE SENSOR)
Applicant
INOVISE MEDICAL, INC.
8770 SW NIMBUS AVE.
SUITE D
Beaverton,  OR  97008
Applicant Contact EARL ANDERSON
Correspondent
INOVISE MEDICAL, INC.
8770 SW NIMBUS AVE.
SUITE D
Beaverton,  OR  97008
Correspondent Contact EARL ANDERSON
Regulation Number870.2800
Classification Product Code
MLO  
Subsequent Product Code
MNR  
Date Received03/12/2013
Decision Date 10/11/2013
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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