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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 K151433
Device Name AUDICOR CA300/CC100 Analyzer with SDB
Applicant
INOVISE MEDICAL, INC.
8770 SW NIMBUS AVENUE
SUITE D
beaverton,  OR  97008
Applicant Contact earl anderson
Correspondent
INOVISE MEDICAL, INC.
8770 SW NIMBUS AVENUE
SUITE D
beaverton,  OR  97008
Correspondent Contact earl anderson
Regulation Number868.2375
Classification Product Code
MNR  
Subsequent Product Code
MLO  
Date Received05/28/2015
Decision Date 03/18/2016
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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