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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 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 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
Predetermined Change
Control Plan Authorized		 No
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