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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilatory effort recorder
510(k) Number K131883
Device Name AUDICOR CPAM WITH SDB (ACCELEROMETER BASED)
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 Number868.2375
Classification Product Code
MNR  
Subsequent Product Code
MLO  
Date Received06/25/2013
Decision Date 04/11/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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