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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
Predetermined Change
Control Plan Authorized		 No
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