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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Stethoscope, Electronic
510(k) Number K103516
Device Name AUDICOR SENSOR-ADAPTER MODEL AUDICOR SENSOR-ADAPTER 4.0
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 Number870.1875
Classification Product Code
DQD  
Subsequent Product Code
DRX  
Date Received11/30/2010
Decision Date 02/04/2011
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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