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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 K112514
Device Name APNEA RISK EVALUATION SYSTEM (ARES)
Applicant
Advanced Brain Monitoring, Inc.
2511 Fox River Cir.
Waukesha,  WI  53189
Applicant Contact ADRIENNE LENZ
Correspondent
Advanced Brain Monitoring, Inc.
2511 Fox River Cir.
Waukesha,  WI  53189
Correspondent Contact ADRIENNE LENZ
Regulation Number868.2375
Classification Product Code
MNR  
Date Received08/30/2011
Decision Date 01/09/2012
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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